Institutional Review Board

UMC Research Study Listing

This webpage lists all active research studies that have been approved by the UMC IRB.  These research studies, also called clinical trials, are made available for public view to encourage collaboration and invite questions about participation. 

The title and brief description of each active study is displayed.  If you have questions about a particular research study, please call the Principal Investigator whose name appears on the listing for that study.

Being in a clinical trial is different from being treated as a patient.  If you choose to participate in a clinical trial, you will become a research subject. Clinical trials are done because researchers want to answer scientific questions and to advance medical knowledge.

The answers may offer benefits to society and to future patients, but it is important to understand that you, as an individual research subject, may or may not benefit from participating in a clinical trial.

If you want more detailed information about what it means to be a research subject in a clinical trial, the National Institutes of Health has prepared a page with answers to some commonly asked questions.

You may also have questions about the specific study you’re considering participating in. If you need clarification about risks, benefits, or anything else related to your particular study be sure to ask the Principal Investigator in your initial discussion.

Protocol ID Protocol Title Protocol Summary Investigator Contact
12.10.001 Simulation-based Training Model to Assist Obstetrical Residents and Sonographers in Learning to Share "Bad News" Regarding Perinatal Abnormality and Loss. The purpose of this study is to test the feasibility of a simulated communication curriculum to assist practitioners in shargin "bad news" during perinatal sonography. Jackson M.D., David  (702)671-5025
12.09.008 SWOG S1115: Randomized Phase II Clinical Trial of AZD6244 Hydrogen Sulfate (NSC-748727) and MK-2206 (NSC-749607) VS mFOLFOX in Patients with Metastatic Pancreatic Cancer After Prior Chemotherapy. The purpose of this study is to assess overall survival in patients with metastatic pancreatic cancer treated with the combination of AZD6244 hydrogen sulfate and MK-2206 compared to those treated with mFOLFOX. Ellerton M.D., John A.  (702)384-0013
12.09.007 NCCTG N0879: A Randomized Phase II Trial of Carboplatin, Paclitaxel, Bevacizumab, with or without Everolimus for Therapy of Metastatic Malignant Melanoma. The purpose of this study is to assess whether there is sufficient promise of an impact on PFS with addition of everolimus to the combination of carboplatin, paclitaxel, and bevacizumab that it would be recommended for further testing in this patient population. Ellerton M.D., John A.  (702)384-0013
12.09.006 RTOG 0938: A Randomized Phase II Trial of Hypofractionated Radiotherapy for favorable Risk Prostate Cancer. The purpose of this study is to demonstrate that 1-year health-related quality of life (HRQOL) for at least one hypofractionated arm is not significantly lower than baseline as measured by the Bowel and Urinary domains of the Expanded Prostate Cancer Index Composite (EPIC) instrument. Meoz M.D., Raul T.  (702)384-0013
12.09.005 ECOG E2810: Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy. The purpose of this study is to evaluate disease-free survival with pazopanib as compared to placebo, defined as the time from randomization to the development of recurrent disease, second primary cancer (other than localized breast, localized prostate, or non-melanoma skin cancer) or death from any cause for patients with metastatic RCC with no evidence of disease following metastatectomy. Ellerton M.D., John A.  (702)384-0013
12.09.001 CommPro Survey: How prevalent are major lapses in physician provider communication skills and professionalism in the University Medical Center Emergency Department? The purpose of this study is to quantify communication skills and frofessionalism in the emergency department, and to record the overall prevalence of lapses in communication and professionalism without any link to individuals. Epter D.O., Michael  (702)383-1880
12.08.005 GOG-3001/20101129: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers The purpose of this study is to determine if 6 cycles of paclitaxel and carboplatin plus AMG 386 followed by 18 months of AMG 386 maintenance improves progression-free survival (PFS) compared to 6 cycles of paclitaxel and carboplatin plus AMG 386 placebo followed by 18 months of AMG 386 placebo maintenance in the first-line treatment of subjects with FIGO Stage III-IV epithelial ovarian, primary peritoneal or fallopian tube cancers. Spirtos M.D., Nicola M  (702)851-4718
12.07.006 GOG-0277: A Phase III Randomized Trial of Gemcitabine (NSC #613327) Plus Docetaxel (NSC #628503) Followed by Doxorubicin (NSC #123127) Versus Observation for Uterus-Limited, High-Grade Uterine Leiomyosarcoma The current standard management for patients with leiomyosarcoma of the uterus which has been completely removed by surgery is to follow patients closely to check if the leiomyosarcoma comes back. Many patients may remain without any evidence of the cancer coming back after having had surgery to take out the leiomyosarcoma. In some patients, however, the leiomyosarcoma does come back. Currently when leiomyosarcoma comes back (recurs) the leiomyosarcoma may be treated with chemotherapy. There are several chemotherapy drugs that can shrink leiomyosarcoma tumors. These include the combination treatment of gemcitabine and docetaxel, and another drug called doxorubicin. In this study, we are looking to see if giving chemotherapy with gemcitabine plus docetaxel, followed by doxorubicin, to patients whose leiomyosarcoma was found only in the uterus, decreases the chance that the leiomyosarcoma will come back. In this study half the patients will be managed in the standard way, which is to follow them closely with CT scans, and see if the disease ever comes back. This will be called the “Standard Treatment Group or Group A.” The other half of the patients will be treated with chemotherapy and also be followed to see if the disease comes back. This will be the “Experimental Treatment Group or Group B.” We will learn whether or not the chemotherapy lowers the chance of the leiomyosarcoma coming back and whether or not the patients who are treated with chemotherapy live longer than the patients who are observed. Spirtos M.D., Nicola M  (702)851-4717
12.07.005 GOG-0244: The Lymphedema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and Impact in Newly Diagnosed Patients The purpose of this study is to find out how often women with gynecologic cancer may develop lower extremity lymphedema (swelling in the legs or a swollen leg) after undergoing surgery to remove tumor and surrounding tissue for gynecologic cancer. Lymphedema is a recurring condition in which excessive fluid stays in the body causing swelling, especially in arms or legs. Lymphedema can occur after damage to, or blockage of, the lymph vessels. Lymph vessels return water and proteins (lymph) from various tissues back to the bloodstream. Damage to lymph vessels may be a result of surgery, chemotherapy and/or radiation therapy used to treat a gynecologic cancer. This condition can vary in severity from mild to severe and can affect people in different ways. In this particular study we are looking at the development of lymphedema in the leg area. Another purpose of this study is to see if certain patient characteristics or surgery factors increase a patient’s risk of developing lower extremity lymphedema. Finally, this study will also look at how the development of lower extremity lymphedema impacts a person’s quality of life. Spirtos M.D., Nicola M  (702)851-4716
12.07.004 AMPED (Acute Management of Pain from the Emergency Department) Phase IV prospective observational registry Acute Management of Pain From the Emergency Department: A National, Emergency Department-Based Prospective Post-Intervention Registry of Non-Opioid and Opioid Management of Acute Pain The purpose of this study is to assess patient-recorded outcomes of pain control medications prescribed in the ER after visits for specific painful injuries/illnesses. Cleveland M.D., Nathan (702)383-1880
12.07.001 LAI116482: A Phase IIb, dose ranging study of oral GSK1265744 in combination with nucleoside reverse transcriptase inhibitors for induction of HV-1 virologic suppression followed by an evaluation of maintenance of virologic suppression when oral GSK1265744 is combined with oral rilpivirine in HIV-1 infected, antiretroviral therapy naive adult subjects. The purpose of this study is to select a dose of GSK1265744 for further evaluation as part of a two drug combination ART regimen with rilpivirine for 24 weeks, following a 24 week induction period of GSK1265744 with two NRTIs, in HIV-1 infected, antiretroviral naive subjects. Cade M.D., Jerry L.  (702)384-9102
12.06.003 GOG-0274 / ANZGOG-0902 / RTOG-1174: A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: THE OUTBACK TRIAL (ANZGOG 0902) The primary purpose of this study is to determine if the addition of adjuvant chemotherapy to standard cisplatin-based chemo-radiation improves overall survival. The secondary purpose of the study is to determine progression-free survival rates, acute and long-term toxicities, patterns of disease recurrence, the association between radiation protocol compliance and outcomes and patient quality of life, including psycho-sexual health. Spirtos M.D., Nicola M  (702)851-4715
12.05.008 E3903: Ancillary Laboratory Protocol for the Collection of Diagnostic Material on Patients Considered for ECOG Treatment Trials for Leukemia or Related Hematologic Disorders The purpose of this study is to provide a mechanism for sample collection and submission for diagnostic review to determine eligibility of patients for accrual to ECOG leukemia trials and to obtain baseline materials for correlative studies outlined in parent clinical protocols. Ellerton M.D., John A.  (702)384-0013
12.05.007 A Phase III Randomized Clinical Trial of Laparoscopic or Robotic Radical Hysterectomy versus Abdominal Radical Hysterectomy in Patients with Early Stage Cervical Cancer The purpose of this study is compare disease-free survival amongst patients who undergo a total laparoscopic (TLRH) or robotic radical hysterectomy (TRRH) verses those who undergo a total abdominal radical hysterectomy (TARH) for early stage cervical cancer. Spirtos M.D., Nicola M  (702)851-4714
12.05.005 RTOG 1114: Phase II Randomized Study of Rituximab, Methotrexate, Procarbazine, Vincristine, and Cytarabine With and Without Low-Dose Whole-Brain Radiotherapy for Primary Central Nervous System Lymphoma. The purpose of this study is to determine median progression-free survival (PFS) in both arms on an intent-to-treat basis. PFS will be defined as the interval from randomization to progression or death, whichever occurs first. Ellerton M.D., John A.  (702)384-0013
12.05.004 RTOG 0933: A Phase II Trial of Hippocampal Avoidance During Whole Brain Radiotherapy for Brain Metastases. The purpose of this study is to evaluate delayed recall as assessed by the Hopkins Verbal Learning Test-Revised (HVTL-R) 4 months after hippocampal avoidance during whole-brain radiotherapy (HA-WBRT) for brain metastasis. Ellerton M.D., John A.  (702)384-0013
12.05.003 RTOG 1008: A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors. The purpose of this study is to determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors. Ellerton M.D., John A.  (702)384-0013
12.05.002 NSABP B-49: A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer. The purpose of this study is to determine if the TC regimen is non-inferior to the anthracycline-based chemotherapy regimens in terms of invasive disease-free survival (IDFS) by combining B-49 data with the AC and TC arms of BSABP B-46-I/USOR 07132 and the data from USOR 06-090. Ellerton M.D., John A.  (702)384-0013
12.05.001 RTOG 1016: Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer The purpose of this study is to determine whether substitution of cisplatin with cetuximab will result in comparable 5-year overall survival. Ellerton M.D., John A.  (702)384-0013
12.04.010 A Simple Intervention to Improve Wound Healing: Targeted Amino Acid Supplementation in Diabetic Foot Wounds The purpose of this study is to evaluate the utility of targeted amino acid supplementation, or Juven, (arginine, glutamine, HMB) in patients with diabetic foot wounds in increasing tissue collagen levels. We aim to prove that a safe, easy to consume, preexisting oral compound (Juven) will increase collagen density (measured via hydroxyproline levels), lean body mass, and decrease surgical complications with diabetic foot wounds undergoing debridement. Barber M.D., Annabel E.  (702)671-2298
12.04.009 GOG-0258: A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma. The purpose of this study is to determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of recurrence or death (i.e., increases recurrence-free survival) when compared to chemotherapy consisting of carboplatin and paclitaxel for 6 cycles (control arm) in patients with Stages III-IVA endometrial carcinoma (<2 cm residual disease) or patients with FIGO 2009 Stage I or II serous (UPSC) or clear cell endometrial carcinoma and positive cytology. Ellerton M.D., John A.  (702)384-0013
12.04.005 GOG-0249: A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed by Paclitaxel/Carboplatin Chemotherapy in Patients with High-Risk, Early Stage Endometrial Carcinoma. The purpose of this study is to determine if treatment with vaginl cuff brachytherapy followed by three cycles of chemotherapy reduces the rate of recurrence or death (i.e. increases recurrence-free survival) when compared to pelvicradiation therapy. Ellerton M.D., John A.  (702)384-0013
12.04.004 GOG-0238: A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients With Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus. The purpose of this study is to assess whether pelvic radiation therapy with concurrent cisplatin is more promising with respect to progression-free survival than pelvic radiation therapy alone in the treatment of recurrent uterine carcinoma limited to the pelvis and vagina. Ellerton M.D., John A.  (702)384-0013
12.03.007 H7T-US-B007(1): TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome [TRANSLATE-ACS] Prospective, Open Label, Anti-Platelet Therapy Study (POPS) The purpose of this study is to determine if the availability of platelet function test results (using the VerifyNow P2Y12 assay) will impact the incidence of therapeutic adjustments to ADP receptor inhibitor treatment through discharge from index hospitalization in MI patients undergoing PCI. Ahsan M.D., Chowdhury  (702)383-2585
12.03.006 GOG-0260: A Phase II Evaluation of Elesclomol Sodium and Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer (Sponsor: GOG, IND #110072) The purpose of this study is to estimate the antitumor activity of elesclomol and paclitaxel in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer primarily through the frequency of objective tumor responses, and to determine the nature and degree of toxicity of elesclomol and paclitaxel in this cohort of patients. Spirtos M.D., Nicola M  (702)851-4713
12.03.004 GOG-0229K: A Phase II Evaluation of BIBF 1120 (IND #113086) in the Treatment of Recurrent or Persistent Endometrial Carcinoma The purpose of this study is to estimate the proportion of patients with persistent or recurrent endometrial cancer, who survive progression-free without going on a subsequent therapy against the disease for at least 6 months and the proportion of patients who have objective tumor response, and to determine the nature and degree of toxicity of BIBF 1120 in this cohort of patients. Spirtos M.D., Nicola M  (702)851-4712
12.03.003 GOG-0227G: A Phase II Evaluation of Brivanib (BMS582664, IND #108417) in the Treatment of Persistent or Recurrent Carcinoma of the Cervix (BMS Study CA182-048) The purpose of this study is to estimate the proportion of patients with persistent or recurrent cervical cancer, who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response (complete or partial), treated with brivanib and to determine the nature and degree of toxicity of brivanib in this cohort of patients. Spirtos M.D., Nicola M  (702)851-4711
12.02.018 ACNS0822: A Randomized Phase II/III Study of Vorinostat (IND# 71976) and Local Irradiation OR Temozolomide and Local Irradiation OR Bevacizumab (IND# 7921) and Local Irradiation Followed by Maintenance Bevacizumab and Temozolomide in Children with Newly Diagnosed High-Grade Gliomas The purpose of this study is to identify the dose of vorinostat that is feasible when given in combination with radiotherapy (RT) in patients with newly diagnosed high-grade gliomas (HGG). The phase II objective is to evaluate if either vorinostat (using MTD from feasibility phase) or bevacizumab gives a more promising outcome compared to temozolomide, as measured by one-year event-free survival (EFS), when given in combination with radiotherapy (RT) followed by maintenance chemotherapy with bevacizumab and temozolomide in patients with newly diagnosed high-grade gliomas (HGG). The Phase III objective is to determine if the agent that has a more promising outcome than temozolomide in the Phase II portion, or the agent with the higher outcome between vorinostat and bevacizumab if both are more promising that temozolomide in the Phase II portion, results in superior event-free survival (EFS) compared to temozolomide, when given in combination with radiotherapy (RT) followed by maintenance chemotherapy with bevacizumab and temozolomide in patients with newly diagnosed high-grade gliomas (HGG). Bernstein M.D., Jonathan  (702)384-0013
12.02.017 Humanitarian Use Device(HUD): Codman Enterprise Vascular Reconstruction Device and Delivery System The purpose of this request is the PI is seeking IRB approval for the use of the CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System as a HUD. The FDA requires IRB review and approval prior to the treating physician's use of the HUD to treat or diagnose patients at a healthcare facility. This clinical use, however, is limited to the indication specified in the product labeling. There is no specific objective/purpose since this is not a research study. The patient population includes patients with angiographically documented wide-neck, intracranial, saccular or fusiform aneurysms, either ruptured or unruptured, arising from a parent vessel with a diameter of 2.5 mm and 4 mm, who are deemed by the PI to be acceptable candidates for endovascular embolization. The CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System is authorized by the Federal law for use with embolic coils. The effectiveness of this device for this use has not been demonstrated. Stent placement in combination with coiling may provide unique opportunities to treat wide-neck intracranial aneurysms by offering the potential for treatment without compromising the parent artery lumen and preventing coil herniation into the parent vessel. Douds M.D., Gregory L.  (702)737-1948
12.02.015 Procalcitonin (PCT) Levels in Chronic Illness The purpose of this study is to define mean value of blood procalcitonin levels in chronically ill patients. Greenberg M.D., Alan  (702)383-7815
12.02.014 A Phase II Evaluation of Ixabepilone (IND #59699, NSC #710428) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus The purpose of this study is to determine the response rate (complete and partial responses by RECIST 1.1) of ixabepilone in patients with recurrent or persistent leiomyosarcoma of the uterus who have failed one previous chemotherapy regimen. To determine the nature and degree of toxicity of ixabepilone as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 in this cohort of patients. Spirtos M.D., Nicola M  (702)851-4710
12.02.013 GOG-0186J: A Randomized Phase II Evaluation of Weekly Paclitaxel (NSC #673089) Plus Pazopanib (NSC #737754)(IND #75648) Versus Weekly Paclitaxel Plus Placebo in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma The purpose of this study is to estimate the progression-free survival hazard ration of the combination of weekly paclitaxel and pazopanib compared to weekly paclitaxel and placebo in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer. To determine the frequency and severity of adverse events as assessed by CTCAE. Spirtos M.D., Nicola M  (702)851-4709
12.02.012 GOG-0186I: A Randomized Phase II Evaluation of Single-Agent Bevacizumab (IND #7921) (NSC #704865) and Combination Bevacizumab with Fosbretabulin Tromethamine (CA4P) (NSC #752293) in the Treatment of Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma The purpose of this study is to estimate the progression-free survival hazard ration of the combination of bevacizumab and fosbretabulin tromethamine (CA4P) compared to bevacizumab alone in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer. To determine the nature and degree of toxicity of fosbretabulin tromethamine plus bevacizumab. Spirtos M.D., Nicola M  (702)851-4708
12.02.011 GOG-0130F: A Phase II Evaluation of Ixabepilone (IND #59699, NSC #710428) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus The purpose of this study is to determine the response rate of ixabepilone in patients with persistent or recurrent carcinosarcoma of the uterus. To determine the nature and degree of toxicity of ixabepilone in this cohort of patients. To determine the duration of progression-free survival and overall survival. Spirtos M.D., Nicola M  (702)851-4707
12.02.009 E3108: A Phase II Prospective Trial Correlating Progression Free Survival with CYP2D6 Activity in Patients with Metastatic Breast Cancer Treated with Single Agent Tamoxifen The purpose of this study is to correlate CYP2D6 score (0 vs. 1+2) and progression-free survival. Ellerton M.D., John A.  (702)384-0013
12.02.007 NSABP B-43: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently With Radiation Therapy and Radiation Therapy Alone for Women With HER2-Positive Ductal Carcinoma In Situ Resected By Lumpectomy. The purpose of this study is to determine whether Trastuzumab given concurrently with radiation therapy (RT) is more beneficial in preventing subsequent ipsilateral breast cancer recurrence, ipsilateral skin cancer recurrence, or ipsilateral DCIS, when compared with RT alone in women with HER2-Positive ductal carcinoma in situ (DCIS) resected by lumpectomy. Ellerton M.D., John A.  (702)384-0013
12.02.006 NSABP B-47: A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer The purpose of this study is to determine whether the addition of Trastuzumab to standard chemotherapy regimens improves invasive disease-free survival relative to chemotherapy alone. Ellerton M.D., John A.  (702)384-0013
12.02.005 SWOG S1007: A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients With 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer With Recurrence Score (RS) of 25 or Less The purpose of this study is to determine the effect of chemotherapy in patients with node positive breast cancer who do not have high Recurrence Scores (RS) by Oncotype DX. In patients with 1-3 positive nodes, and hormone receptor (HR)-positive, HER2-negative breast cancer with RS<25 treated with endocrine therapy we will test whether the difference in disease-free survival for patients treated with chemotherapy compared to no chemotherapy depends directly on the magnitude of RS. If benefit depends on the RS score, the trial will determine the optimal cut point for recommending chemotherapy or not. Ellerton M.D., John A.  (702)384-0013
12.02.004 WFU 97609: Impact of Genomics and Exposures on Disparities in Breast Cancer Radiosensitivity. The purpose of this study is to develop and validate prediction biomarkers for RT-induced acute and chronic skin reactions and quality of life in five racial/ethnic groups of breast cancer patients, Whites, Black/African Americans (AA), Hispanic/Latinos, Asians/Native Hawaiians/Pacific Islanders, and American Indians/Alaskan Natives. Ellerton M.D., John A.  (702)384-0013
12.02.003 COG: ARAR0332, Treatment of Adrenocortical Tumors with Surgery plus Lymph Node Dissection and Multiagent Chemotherapy, A Groupwide Phase III Study The purpose of this study is to describe the outcome of patients with Stage I adrenocortical tumors (ACT) who are treated with surgery alone; to describe the outcome of patients with Stage II ACT who are treated with radical adrenalectomy plus regional retroperitoneal lymph node dissection (RPLND); to describe the outcome of patients with unresectable or metastatic adrenocortical carcinoma who are treated with mitotane and a cisplatin-based chemotherapy regimen. Bernstein M.D., Jonathan  (702)384-0013
12.01.021 Linguistic characteristics of Internationally Educated Nurse Discourse The purpose of this study is to determine the linguistic characteristics of internationally educated nurses (IENs) in comparison with American born nurses (ABNs). Slattery M.D., David E.  (702)383-1880
12.01.015 Culture and Characterization of Circulating Tumor Cells (CTC) from Patients with Malignant Melanoma and Other Cancers The purpose of this study is to evaluate the feasibility and reproducibility of isolation of circulating tumor cells (CTC) using newly developed TrueCells cell culture technology. Optimize quantitative CTC recovery in the TrueCells assay. Provide preliminary data concerning correlation of these measurements with other measure of CTC recovery, such as immunofluorescent or lipid-based staining. Samlowski M.D., Wolfram E  (702)952-1251
12.01.014 ECOG E1908: A Phase II Randomized Trial Comparing Standard and Low Dose Rituximab: Initial Treatment of Progressive Chronic Lymphocytic Leukemia in Elderly Patients Using Alemtuzumab and Rituximab The purpose of this study is to compare the rate of complete and overall response of patients treated with the two regimens to determine if the use of modified dose rituximab significantly affects outcome. Ellerton M.D., John A.  (702)384-0013
12.01.012 GOG-0267: Quality of Life and Care Needs in Patients with Persistent or Recurrent Platinum-Resistant Ovarian, Fallopian Tube, and Peritoneal Cancer The purpose of this study is to determine the prevalence and severity of patient-reported symptoms in patients with platinum resistant ovarian, fallopian and peritoneal cancers at study entry, 3 months, and 6 months post-enrollment. Spirtos M.D., Nicola M  (702)851-4706
12.01.011 GOG-0273: Chemotherapy Toxicity in Elderly Women with Ovarian, Primary Peritoneal or Fallopian Tube Cancer The purpose of this study is to determine whether the score on IADL obtained at time of registration is associated with the ability of patients to complete four cycles of chemotherapy without dose reduction or a more than 7 day delay. To estimate by regimen the percentage of patients who are able to complete four cycles of chemotherapy regardless of dose reductions and delays. To compare actual and calculated carboplatin AUC in this patient population. Spirtos M.D., Nicola M  (702)851-4705
12.01.010 GOG-0186G: A Phase II Randomized, Double-Blinded Evaluation of Oral Everolimus (RAD001) Plus Bevacizumab Vs. Oral Placebo Plus Bevacizumab in the Treatment of Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer The purpose of this study is to estimate the progression-free survival hazard ratio of the combination of oral everolimus (RAD001) and bevacizumab compared to oral placebo and bevacizumab in patients with persistent or recurrent ovarian fallopian tube, or primary peritoneal cancer. Spirtos M.D., Nicola M  (702)851-4704
12.01.008 E2906: Phase III Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin & Cytarabine Induction and Intermediate Does Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age > or equal to 60 years) The purpose of the study is to evaluate the effect of clofarabine induction and consolidation therapy on overall survival in comparison with standard therapy (daunorubicin & cytarabine) in newly-diagnosed AML patients age > or equal to 60 years. Ellerton M.D., John A.  (702)384-0013
12.01.007 ECOG: E3A06, Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma The purpose of this study is to compare progression free survival where failure is defined as death or the development of symptomatic myeloma indicating treatment between patients receiving lenalidomide versus observation alone in high-risk asymptomatic, smoldering multiple myeloma. Ellerton M.D., John A.  (702)384-0013
12.01.006 CALGB 10404: A Genetic Risk Stratified, Randomized Phase II Study of Four Fludarabine/Antibody Combinations for Patients with Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia (CLL). The purpose of the study is to determine the two-year progression-free survival (PFS) after remission induction with four different chemo-immunotherapy combinations for patients with untreated, symptomatic, lower risk and high risk chronic lymphocytic leukemia (CLL) to decide which of the four arms, if any, to take forward into a randomized phase III Trial. Ellerton M.D., John A.  (702)384-0013
11.11.005 Tobacco Cessation Study: Tobacco cessation intervention among emergency department patients and visitors utilizing volunteer research associates The purpose of this study is to examine an RA-administered assessment of tobacco use among non-emergency patients and their visitors in fifteen hospitals across the country to determine the outcomes for those participants who are offered referral to tobacco Quitlines. While patients and visitors are waiting in their ED room they will be approached given a verbal description of the study and what their role would be in the study through a formal Verbal Assent. If the patient or visitor provides verbal assent they will be included in the study as a subject. A series of questions will be asked and depending on the answers the subject will be offered a referral to a tobacco cessation program. Slattery M.D., David E.  (702)383-1880
11.11.003 COG AALL1131: CIRB: A Phase III Randomized Trial for Newly Diagnosed High Risk B-precursor Acute Lymphoblastic Leukemia (ALL) Testing Clofarabine in the Very High Risk Stratum The purpose of this study is to: For subjects with very high risk (VHR) and high risk(HR) ALL receiving Induction therapy, the primary goal is to collect information about their leukemia and about the effects of the first phase of treatment called Induction. For subjects with HR-ALL receiving post-induction therapy, the primary goal is to find out if using triple intrathecal therapy (ITT), improves survival rates better than using standard intrathecal therapy (IT) with methotrexate (MTX) alone given in the spinal fluid; the effects will be compared to find out which is better; as well as to better understand the effects of cancer treatment in people with HR-ALL. For subjects with VHR-ALL receiving post-induction therapy, the primary goal is to find out if using Experimental Arm 1 or Experimental Arm 2 improves survival rates better than the Control Arm. Find out if using Experimental Arm 2 improves survival rates better than Experimental Arm 1, compare the effects of using either Experimental Arm 1 or Experimental Arm 2 to the Control Arm. For subjects with Down Syndrome (DS) HR ALL, the primary goal is to find out if children with DS HR-ALL will have improved outcomes with a less intense therapy given during the Induction phase of therapy, find out if children with DS HR-ALL will have improved outcomes with fewer courses of prednisone and vincristine given during the Maintenance phase of chemotherapy; Find out if outcomes have improved as well as the effects. Bernstein M.D., Jonathan  (702)384-0013
11.11.002 COG ACCL0922: CIRB: A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor The purpose of this study is to determine whether a 6-week drug trial of modafinil, compared to placebo, is associated with improvement in neurocognitive function as defined by parent report of inattention or working memory deficits or by direct assessment of attention, working memory or processing speed in children with cognitive impairment after treatment for a primary brain tumor. Bernstein M.D., Jonathan  (702)384-0013
11.10.004 ACNS0821: Temozolomide with Irinotecan versus Temozolomide, Irinotecan plus Bevacizumab for Recurrent/Refractory Medulloblastoma/CNS PNET of Childhood, A COG Randomized Phase II Screening Trial The purpose of this study is to compare the overall survival (OS) of subjects receiving the combination of temozolomide and irinotecan with that of subjects receiving temozolomide, irinotecan and bevacizumab for recurrent medulloblastoma (MB)/PNET of childhood. Bernstein M.D., Jonathan  (702)384-0013
11.10.003 AOST06B1: A Children's Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens The purpose of this study is to collect and provide a repository for biological specimens with osteosarcoma. These specimens will be available to qualified researchers to understand the biology of osteosarcoma and correlate these results with the patient's clinical data. Bernstein M.D., Jonathan  (702)384-0013
11.10.002 ACCL0934: A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplant (HSCT) The purpose of this study is to determine if levofloxacin given prophylactically during periods of neutropenia to patients being treated with chemotherapy for AL or undergoing HSCT will decrease the incidence of bacteremia. Bernstein M.D., Jonathan  (702)384-0013
11.09.009 SWOG S1014: Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II. The purpose of this study is to assess the rate of achieving a PSA of less than or equal to 0.2 ng/ml with abiraterone acetate therapy in men with metastatic prostate cancer with a suboptimal response to androgen deprivation therapy (ADT). The undetectable level of PSA will be confirmed by a second measurement with a PSA less than or equal to 0.2ng/ml at least 4 weeks later, without any evidence for progression. Subjects who fail to reach and confirm a PSA of less than or equal to 0.2ng/ml by 12 months will be considered a non-responder with regard to the primary endpoint. Ellerton M.D., John A.  (702)384-0013
11.09.008 CALGB 80702: A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer The purpose of this study is to compare disease free survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX) or standard chemotherapy (FOLFOX) with 3 years of celecoxib 400 mg daily. Ellerton M.D., John A.  (702)384-0013
11.08.003 Signaling Pathways and Cytokine Activity Within the Breast Carcinoma Metastatic Lymph Node Track and Melanoma Metastic Lymph Node TRack: An Assay of CXCL12 and CXCR4/VEGF in Ductal Lymphatic Epithelium. The purpose of this study is to better delineate the exact biochemical microenvironment in which tumor cells reach their final metastatic resting place. Kirgan M.D., Daniel M.  (702)671-5150
11.08.002 NVCI 11-15: Cultured circulating tumor cells - development of a novel platform for drug discovery and in vitro chemosensitivity testing in prostate and other cancers. The purpose of this study is to compare colony counts obtained with the 3-D growth method before and after initiation of treatment with CTC (circulating tumor cell) counts obtained using Cellsearch, to evaluate the assay as a predictive tool for prostate and breast cancers. Goodman M.D., Jr, Oscar  (702)822-5433
11.08.001 SWOG S0820: A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary colorectal Cancers in Patients with Stage 0-III Colon Cancer, Phase III The purpose of this study is to determine if eflornithine and sulindac, taken alone or in combination, can decrease the risk of high-risk adenomas or second primary colorectal cancers in patients who have been treated for Stage 0, I, II, or III colon cancer. Ellerton M.D., John A.  (702)384-0013
11.07.005 ECOG E1609: A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-Risk Melanoma The purpose of this study is to evaluate recurrence-free survival (RFS) between patients randomized to receive post-operative adjuvant ipilimumab versus those randomized to receive HDI. Ellerton M.D., John A.  (702)384-0013
11.06.002 URCC 10055: Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy at Pre-treatment, Post-treatment, and at Six Month Follow-up. The purpose of this study is to quantify the difference in memory impairment (via psychometrically validated computerized CANTAB test) in breast cancer (females receiving anthracycline and non-anthracycline regimens) and lymphoma patients (males and females receiving chemotherapy) compared with a control comparison group of the same age and gender at pre-treatment and post-treatment. Ellerton M.D., John A.  (702)384-0013
11.05.006 Genetic and Biochemical Analysis of Patients with Inflammatory Bowel Disease The purpose of this study is to create a database of genetic information (samples of DNA), blood markers that detect inflammation, clinical information, and clinical follow-up to investigate the relationships between genes and inflammatory bowel disease. This database of DNA, clinical characteristics, and biochemical markers will serve as a resource for the study of the association of genetic and biochemical factors with disease and outcome. Scherr MD, Rebecca  (702)992-6868
11.05.004 ACCL0933: A Randomized Open-Label Trial of Caspofungin versus Fluconazole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML). The purpose of this study is to determine if prophylaxis with caspofungin administered during periods of neutropenia following chemotherapy for acute myeloid leukemia (AML) is associated with a lower incidence of proven or probable invasive fungal infections (IFI) compared with fluconazole. Bernstein M.D., Jonathan  (702)384-0013
11.05.003 ARST0921: A Randomized Phase II Trial of Bevacizumab (IND# 7921, Avastin) and Temsirolimus (IND# 61010,Torisel) in Combination with Intravenous Vinorelbine and Cyclophosphamide in Patients with Recurrent/Refractory Rhabdomyosarcoma The purpose of this study is to determine the feasibility of administering bevacizumab in combination with intravenous vinorelbine and cyclophosphamide (VC) in patients with recurrent rhabdomyosarcoma (RMS) as well as administering temsirolimus in combination with VC in patients with recurrent RMS. Another purpose is to estimate the event-free survival (EFS) of patients with recurrent/refractory RMS treated with bevacizumab and VC and compare with the EFS of those treated with temsirolimus and VC. Bernstein M.D., Jonathan  (702)384-0013
11.05.002 SWOG S0931 EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study. The purpose of this study is to compare recurrence-free survival in renal carcinoma patients randomly assigned to one year of everolimus versus one year of placebo after nephrectomy or partial nephrectomy. Ellerton M.D., John A.  (702)384-0013
11.05.001 Tobira 652-2-202: A Phase 2b randomized, double-blind, double-dummy trial of 100 or 200mg once-daily doses of cenicriviroc (CVC, TBR-652) or once-daily EFV, each with open-label FTC/TDF in HIV-1 infected, antiretroviral treatment-naive, adult patients with only CCR5-tropic virus. The purpose of this study is to determine the percentage of patients who achieve HIV-1 RNA levels below 50 copies/ml at week 24 and to compare the safety and tolerability of each CVC regimen versus EFV. Cade M.D., Jerry L.  (702)384-9102
11.04.007 GOG-0127W: A Phase II Evaluation of ABT-888 (IND #77840, NCI Supplied Agent: ABT-888, NSC #737664), Topotecan (NSC #609699) and Filgrastim or Pegfilgrastim in the Treatment of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix The purpose of this study is to estimate the antitumor activity (objective response rate by RECIST 1.1) of ABT-888 10mg administered orally twice a day on days 1 to 5 with Topotecan 0.6mg/m2 administered IV once daily on days 1 to 5 of each cycles in patients with persistent or recurrent carcinoma of the cervix. To determine the nature and degree of toxicity of ABT-888 and Topotecan in patients with persistent or recurrent carcinoma of the cervix. Spirtos M.D., Nicola M  (702)851-4703
11.04.006 GOG-0268: A Phase II Evaluation of Temsirolimus (CCI-779) (NCI Supplied Agent: NSC #683864, IND #61010) in Combination with Carboplatin and Paclitaxel Followed by Temsirolimus (CCI-779) Consolidation as First-Line Therapy in the Treatment of Stage III-IV Clear Cell Carcinoma of the Ovary The purpose of this study is to assess the activity of the study regimen as measured by the proportion of patients who are alive and progression-free for at least 12 months after study entry in patients with newly diagnosed Stage III or IV clear cell ovarian cancer. Spirtos M.D., Nicola M  (702)851-4702
11.04.004 GOG-0241: A GCIG Intergroup Multicenter Phase III Trial of Open Label Carboplatin and Paclitaxel +/- Bevacizumab (NSC #704865, IND #7921)Compared with Oxaliplatin and Capecitabine +/- Bevacizumab as First Line Chemotherapy in Patients with Mucinous Epithelial Ovarian or Fallopian Tube Cancer (MEOC) The purpose of this study is to determine if Capecitabine and Oxaliplatin reduces the death rate compared to Carboplatin and Paclitaxel in women with mucinous Adenocarcinoma of the ovary or fallopian tube. To determine if Bevacizumab reduces the death rate compared to no Bevacizumab in women with mucinous Adenocarcinoma of the ovary or fallopian tube. Spirtos M.D., Nicola M  (702)851-4701
11.03.013 Comparison of Metabolic Rate between the MedGem Devise and a Predicted Energy Expenditure Formula. The purpose of this study is to determine the metabolic expenditure of children/adults comparing a hand held device called the MedGem to a dedicated formula commonly used by clinicians. The two methods will be compared to see how well they correlate. Hart M.D., Benjamin  (702)383-3642
11.03.007 GOG-0224: A Randomized Phase II Evaluation of Continuous Progestin Therapy vs. Sequential Progestin Therapy in the Treatment of Endometrial Intraepithelial Neoplasia (EIN) From a Referred Cohort of Atypical Endometrial Hyperplasia (AEH) or EIN Patients that Desire Uterine Preservation The purpose of this study is to determine the frequency of complete remission by a central pathology review panel in diagnosed EIN patients treated for 24 weeks with oral continuous versus interrupted progestin therapy. Complete remission will be defined as resolution to the target lesion in the re-evaluation biopsies. To evaluate whether quality of life is superior in patients who take continuous megestrol versus sequential megestrol by evaluating mood, concerns about weight changes and bleeding. Spirtos M.D., Nicola M  (702)851-4700
11.03.003 SWOG S0816: A Phase II Trial of Response Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging. The purpose of this study is to estimate the 2 year progression free survival (PFS) in HIV-negative patients with advanced stage Hodgkin Lymphoma treated with response-adapted therapy based on FDG-PET imaging after 2 cycles of adriamycin, bleomycin, vinblastine, and dacarbazine (ABVD). Also to estimate the 2 year PFS in the subset of HIV-negative patients with advanced stage HL who are PET-positive after 2 cycles of ABVD and are subsequently treated with escalated dose BEACOPP. Ellerton M.D., John A.  (702)384-0013
11.03.002 CALGB 50604: A Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma. The purpose of this study is to determine the progression-free survival (PFS) from enrollment for patients with non-bulky stage I and II Hodgkin lymphoma. All patients will begin treatment with ABVD. The chemotherapy regimen (ABVD or escalated BEACOPP) and the possible addition of IFRT will be determined by response as assessed by PET imaging after two cycles. The primary endpoint will be the PFS for patients that are PET negative following 2 cycles of ABVD for whom treatment will consist of 2 additional cycles of ABVD without RT. The second primary objective will be to compare the PFS of patients who are PET positive versus PET negative following 2 cycles of ABVD. Patients who are PET positive after the initial 2 cycles of ABVD will receive 2 cycles of escalated BEACOPP and IFRT. Ellerton M.D., John A.  (702)384-0013
11.02.006 What Are The Characteristics Of Lifeguard Medical Team (Medical Team) Patient Encounters Amongst Beaches In Ecuador During Carnivale 2011? The purpose of this study is to determine the characteristics of encounters with the Medical Team for all rescue, prevention, and first aid subjects on beaches in Ecuador during Carnivale 2011. Slattery M.D., David E.  (702)383-1880
11.02.005 CALGB 70807: The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance. The purpose of this study is to determine if a telephone-based dietary intervention compared to no intervention will decrease clinical progression in prostate cancer patients. Ellerton M.D., John A.  (702)384-0013
11.02.004 CALGB 10403: An Intergroup Phase II Clinical Trial for Adolescents and Young Adults with Untreated Acute Lymphoblastic Leukemia (ALL). The purpose of this study is to improve the outcome of adolescents and young adults with acute lymphoblastic leukemia (ALL). This study will evaluate the effectiveness and side-effects of an intensive program using multiple chemotherapy drugs that has been designed for children but is now being used in young adults up to 40 years. A comparison of the outcomes of patients treated by adult hematologists and oncologists on this study with the outcomes of similar patients treated with the same chemotherapy program by pediatric oncologists. Ellerton M.D., John A.  (702)384-0013
11.02.001 RTOG 1010: A Phase III Trial Evaluating The Addition Of Trastuzumab To Trimodality Treatment Of HER2-Overexpressing Esophageal Adenocarcinoma The purpose of this study is to determine if Trastuzumab increases disease-free survival when combined with chemotherapy plus radiation, followed by surgery (trimodality treatment) for patients with HER2-overexpressing esophageal cancer. Ellerton M.D., John A.  (702)384-0013
11.01.007 One Step and Two Steps Laparoscopic Cholecystectomy: A Prospective Comparison Of Two Standard Methods The purpose of this study is to compare two standard methods of treating calculous biliary disease. The two methods are the ONE STEP and TWO STEPS laparoscopic cholecystectomies. Johnson MD, Matthew  (702)719-9059
11.01.006 GOG-0170Q: A Phase II Evaluation Of Intraperitoneal Egen-001 (IL-12 Plasmid Formulated With PEG-PEI-CHOLESTEROL LIPOPOLYMER) (IND #14350) In The Treatment Of Persistent Or Recurrent Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Cancer The purpose of this study is to determine whether EGEN-001 is effective in ovarian, fallopian tube or primary peritoneal cancer, and to determine the frequency and severity of the adverse events as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Spirtos M.D., Nicola M  (702)851-4699
11.01.005 A Randomized Phase II Evaluation Of Weekly Paclitaxel Versus Weekly Paclitaxel With Oncolytic Reovirus (Reolysin® NSC # 729968, BB-IND # 13370) In The Treatment Of Recurrent Or Persistent Ovarian, Fallopian Tube Or Primary Peritoneal Cancer The purpose of this study is to compare the effectiveness and safety of (1) Reolysin and weekly paclitaxel, compared with (2) paclitaxel alone. Thus, there are two "arms" of this study. Spirtos M.D., Nicola M  (702)851-4698
11.01.004 Device: Non-Invasive Hemoglobin Monitoring In Acute Trauma Care The purpose of this study is to determine if the Masimo Radical-7 Pulse Co-Oximeter hemoglobin reading accurately compare to standard laboratory venous blood sample test results in trauma patients. Bledsoe D.O, Bryan  (702)383-1880
11.01.002 CALGB 30901: Randomized Phase II Study of Maintenance Pemetrexed Versus Observation for Patients with Malignant Pleural Mesothelioma without Progression After First-Line Chemotherapy. The purpose of this study is to find out whether continuation of chemotherapy with pemetrexed will increase the time before the mesothelioma begins to grow again. Pemetrexed is approved by the FDA to treat mesothelioma, but exactly how long to continue pemetrexed is not known. Ellerton M.D., John A.  (702)384-0013
11.01.001 COG AEWS1031: A Phase III Randomized Trial of Adding Vincristine-topotecan-cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma. The purpose of this study is to determine if adding the chemotherapy drug topotecan to the standard five-drug chemotherapy regimen will result in better outcomes than the standard five-drug chemotherapy by itself in patients with localized (not spread to other parts of the body) Ewing sarcoma. The secondary objectives are to assess initial tumor volume, histologic response to induction chemotherapy, and response measured by PET scan as prognostic factors for survival in this patient population. Bernstein M.D., Jonathan  (702)384-0013
10.11.002 GOG 0262: A Randomized Phase III Trial of Every 3-Weeks Paclitaxel Versus Dose Dense Weekly Paclitaxel In Combination With Carboplatin With or Without Concurrent And Consolidation Bevacizumab (NSC #704865, IND #7921) In The Treatment of Primary Stage III Or IV Epithelial Ovarian, Peritoneal Or Fallopian Tube Cancer. The purpose of this study is to compare the effectiveness and side effects of paclitaxel given every three weeks versus paclitaxel given once a week, when combined with carboplatin. Spirtos M.D., Nicola M  (702)851-4697
10.11.001 A Phase 3, randomized, double-blind study of the safety and efficacy of GSK1349572 plus abacavir/lamivudine fixed-dose combination therapy administered once daily compared to Atripla over 96 weeks in HIV-1 infected antiretroviral therapy naive adult subjects. The purpose of this study is to test the safety and efficacy (how well the drug works) of GSK1349572. GSK1349572 is NOT approved for doctors to prescribe to patients. Cade M.D., Jerry L.  (702)384-9101
10.10.006 CALGB 90802: CIRB: Randomized Phase III Trial Comparing Everolimus Plus Placebo Versus Everolimus Plus Bevacizumab For Advanced Renal Cell Carcinoma Progressing After Treatment With Tyrosine Kinase Inhibitors. The purpose of this study is to compare the effects of a drug called everolimus alone with those of the combination of everolimus and a drug called bevacizumab for advanced kidney cancer to find out which is better. Ellerton M.D., John A.  (702)384-0013
10.10.002 SWOG S0925 A Randomized Phase II Study of Combined Androgen Deprivation versus Combined Androgen Deprivation with IMC-A12 for Patients With New Hormone-Sensitive Metastatic Prostate Cancer. The purpose of this study is to compare the undetectable PSA rate after 7 cycles of protocol treatment between those randomized to an LHRH agonist and bicalutamide and those randomized to an LHRH agonist bicalutamide and IMC-A-12 Ellerton M.D., John A.  (702)384-0013
10.09.012 COG ARET0321: CIRB: A Trial of Intensive Multi-Modality Therapy for Extra-Ocular Retinoblastoma The purpose of this study is to find out if this multimodality therapy will get rid of your cancer for as long as possible, how well the first phase of the study treatment (induction) makes the tumor shrink or disappear and what effect is good and/or bad that the multimodality therapy has on people with your kind of retinoblastoma. Bernstein M.D., Jonathan  (702)384-0013
10.09.010 A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide, and Cisplatin for Newly Diagnosed Advanced Stage and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary The purpose of this study is to find out whether treatment with the drugs paclitaxel and carboplatin work better to control your cancer than treatment with the drugs bleomycin, etoposide and cisplatin, which is the standard treatment for your type of cancer. Spirtos M.D., Nicola M  (702)851-4696
10.09.009 Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy The purpose of this study is to determine if weekly chemotherapy with cisplatin and simultaneous radiation therapy increases the time you live disease-free compared to radiation therapy alone. Spirtos M.D., Nicola M  (702)851-4695
10.09.008 GOG-0255: A Phase II Randomized, Double-Blind Trial of a Polyvalent Vaccine-KLH Conjugate (NSC #748933, IND #14384) + OPT-821 Versus OPT-821 in Patients with Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Who are in Second or Third Complete Remission The purpose of this study is to study a vaccine treatment for patients with ovarian, fallopian tube or peritoneal cancer and see if the vaccine may be able to delay or prevent your cancer from returning again. Spirtos M.D., Nicola M  (702)851-4694
10.09.006 A Randomized Phase III Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF with Bevacizumab (NSC #704865, IND #7921) Versus Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF with Placebo in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus. NCI Supplied Agent: Bevacizumab (NSC #704865, IND #7921) The purpose of this study is to compare treatment with gemcitabine plus docetaxel to treatment with gemcitabine plus docetaxel plus the addition of a third drug called bevacizumab. Spirtos M.D., Nicola M  (702)851-4693
10.09.003 COG AALL08B1: CIRB: Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) The purpose of this study is to find out the specific subtype of the leukemia you have. Bernstein M.D., Jonathan  (702)384-0013
10.08.012 COG AALL0932: CIRB: Treatment of Patients with Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL) The purpose of this study is to test whether modifications in Maintenance therapy will improve outcomes while minimizing side effects. Bernstein M.D., Jonathan  (702)384-0013
10.08.010 TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (Translate-ACS) Registry. The purpose of this study is to evaluate the effectiveness of these medicines and to examine how doctors prescribe these medications for short and long term use. Ahsan M.D., Chowdhury  (702)383-2585
10.08.009 CALGB 80802: CIRB: Phase III randomized study of sorafenib (IND 69896, NSC 724772) plus doxorubicin versus sorafenib in patients with advanced hepatocellular carcinoma (HCC) The purpose of this study is to compare the effects (good and bad) of the drug sorafenib with the combination of sorafenib plus doxorubicin on you and your advanced primary liver cancer to find out which is better. Ellerton M.D., John A.  (702)384-0013
10.08.008 COG AAML08B1: CIRB: Biology Study of Transient Myeloproliferative Disorder (TMD) IN Children with Down Syndrome (DS) The purpose of this study is to study the biology of TMD to increase our understanding of the disease. Bernstein M.D., Jonathan  (702)384-0013
10.08.005 ANBL0032, Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue The purpose of this study is to try and improve the likelihood that the cancer will not come back in children with high-risk neuroblastoma. Bernstein M.D., Jonathan  (702)384-0013
10.08.002 RTOG 1014-A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBRI) for Local Recurrence of Breast Carcinoma The purpose of this study is to evaluate the side effects of partial breast re-irradiation given after a lumpectomy. Meoz M.D., Raul T.  (702)384-0013
10.07.006 ACNS0831: CIRB: Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years The purpose of this study is to study the effects of surgery, radiation therapy and chemotherapy on learning, thinking, hearing and the production of hormones (substances made in the brain that affect growth and development). Bernstein M.D., Jonathan  (702)384-0013
10.06.010 COG AHOD04B1: CIRB: Hodgkin Disease (HD) Banking Study. The purpose of this study is to collect and distribute samples obtain from subjects with Hodgkin Disease Bernstein M.D., Jonathan  (702)384-0013
10.06.009 COG ANHL04B1: CIRB: Rare and Cutaneous Non-Hodgkin Lymphoma Registry. The purpose of this study is to learn more about lymphoma/LD, how it presents and whether it behave differently from the same lymphoma/LD in adults, what treatment is being used and to register all subject under 21 years who present with an uncommon type of lymphoma/LD or a lymphoma/LD at an uncommon site such as the brain or skin. Bernstein M.D., Jonathan  (702)384-0013
10.06.008 COG ANBL00P3: CIRB: A Phase III Randomized Trial Of Intravenous Gammaglobulin Therapy For Patients With Neuroblastoma Associated Opsoclonus-Myoclonusataxia Syndrome Treated With Chemotherapy And Prednisone The purpose of this is to see whether the use of intravenous gammaglobulin (IVIG) improves the abnormal motor coordination (ataxia, abnormal eye movements (opsoclonus) and muscle twitching (myoclonus). Bernstein M.D., Jonathan  (702)384-0013
10.06.007 COG ACNS02B3: A Children's Oncology Group Protocol For Collecting And Banking Pediatric Brain Tumor Research Specimens The purpose of this study is to find better ways to find tumors early and to prevent the occurrence of tumors and develop better and less toxic therapies. Bernstein M.D., Jonathan  (702)384-0013
10.06.002 COG AHOD0831: CIRB: A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children with Newly Diagnosed High Risk Hodgkin Lymphoma The purpose of this study is to find out if we can use response-based chemotherapy to successfully treat children and young adults with high risk Hodgkin lymphoma. Bernstein M.D., Jonathan  (702)384-0013
10.06.001 COG ARST08P1: CIRB: A Pilot Study to Evaluate Novel Agent Cixutumumab (IMC-A12, Anti-IGF-IR Monoclonal Antibody, IND #100947, NSC # 742460) in Combination with Intensive Multi-Agent Interval Compressed Therapy for Patients with High-Risk Rhabdomyosarcoma The purpose of this study is to see if giving IMC-A12 in combination with high intensity chemotherapy to subjects with high risk rhabdomyosarcoma or ectomesenchymoma. Bernstein M.D., Jonathan  (702)384-0013
10.05.015 SWOG S0819: CIRB: A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/ Bevacizumab With or Without Concurrent Cetuximab In Patients With Advanced Non-Small Cell Lung Cancer (NSCLC). The purpose of this study is to compare the effects of cetuximab on lung cancer. Ellerton M.D., John A.  (702)384-0013
10.05.014 COG ABTR04B1: Establishing Continuous Cell Lines and Exenografts From Pediatric Cancers For Biological and Pre-Clinical Therapeutic For Biological And Pre-Clinical The purpose of this study is find better ways to find tumors early, to find ways to prevent tumors and to develop better and less toxic therapies. Bernstein M.D., Jonathan  (702)384-0013
10.05.012 NSABP P-5: Statin Polyp Prevention Trial in Patients with Resected Colon Cancer. The purpose of this study is to find out whether or not rosuvastatin is able to prevent colon polyps and colorectal cancer from occurring in patients who have already had a colon cancer removed by surgery. Ellerton M.D., John A.  (702)384-0013
10.05.010 COG ARST0531: CIRB: Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) versus VAC Alternating with Vincristine and Irinotecan (VI) for Patients with Intermediate-RiskRhabdomyosarcoma (RMS) The purpose of this study is to see if adding an additional drug combination (vincristine plus irinotecan or VI) is better than VAC alone. Bernstein M.D., Jonathan  (702)384-0013
10.05.007 SWOG S0518: CIRB: Phase III Prospective Randomized Comparison of Depot Octreotide plus interferon Alpha versus Depot Octreotide plus Bevacizumab (NSC 704865) in Advance, Poor Prognosis Carcinoid Patients The purpose of this study is to compare the effects of octreotide plus bevacizumab with octreotide plus interferon on you and your carcinoid tumor to find out which is better. Ellerton M.D., John A.  (702)384-0013
10.05.006 COG AALL0631: CIRB: A Phase III Study of Risk Directed Therapy for Infants with Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND#76431; NSC#617807) The purpose of the study is to see whether making certain changes to the standard treatment will increase the percentage of patients who have their cancer go and stay away with0ut causing unacceptable side effects. Bernstein M.D., Jonathan  (702)384-0013
10.05.005 COG AALL07P1: CIRB: A Phase II Pilot Trial of Bortezomib (PS-341, Velcade®, IND# 58,443) in Combination with Intensive Re-Induction Therapy for Children with Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL) The purpose of the study is to measure how effective the combination of bortezomib with standard chemotherapy drugs is at treating children and young adults with relapsed ALL Bernstein M.D., Jonathan  (702)384-0013
10.05.002 COG AHEP0731: CIRB: Treatment of Children with All Stages of Hepatoblastoma: A Groupwide Phase III Study The purpose of this study is to evaluate whether a rating system be used to decide if a tumor can be removed by surgery? Bernstein M.D., Jonathan  (702)384-0013
10.04.018 COG AALL0433: CIRB: Intensive Treatment for Intermediate-Risk Relapse of Childhood B-Precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies. The purpose of this study is to compare the effects of chemotherapy with a high dose of vincristine against chemotherapy with a standard dose of vincristine. Bernstein M.D., Jonathan  (702)384-0013
10.04.016 RTOG 0848: CIRB: A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma. The purpose of this study is to compare the effects of erlotinib in combination with gemcitabine to gemcitabine alone for patients with pancreatic cancer that was removed by surgery to find out which is better. Ellerton M.D., John A.  (702)384-0013
10.04.012 GOG 0214: Phase II Double Blind Randomized Trial Evaluating the Biologic Effect of Levonorgestrel on the Ovarian Epithelium in Women at High Risk for Ovarian Cancer (IND #79,610) The purpose of this study is to find out whether certain hormones called progestins may play a role in the prevention of ovarian cancer. Spirtos M.D., Nicola M  (702)851-4692
10.04.011 GOG 0187: Phase II Study of Paclitaxel for Ovarian Stromal Tumors as Second-Line Therapy. The purpose of this study is to determine if paclitaxel will cause ovarian stromal tumors to completely disappear at all sites and all places where cancer has been detected. Spirtos M.D., Nicola M  (702)851-4691
10.04.008 GOG-0237: Comparative Analysis of CA-IX, p16, Proliferative Markers and Human Papilloma Virus (HPV) in the Diagnosis of Significant Cervical Lesions in Patients with a Cytologic Diagnosis of Atypical Glandular Cells (AGC) The main purpose of this study is to determine whether the presence of certain biomarkers (factors in the blood and cells) including human papilloma virus (HPV), CA-IX, p16, Ki-67 and MCM2 in a liquid cervical cell specimen can help identify which women with a cytologic diagnosis of AGC have a benign condition and which have a pre-cancerous condition or an invasive cancer that requires surgical removal. Spirtos M.D., Nicola M  (702)851-4690
10.04.005 Seprafilm for the Prevention of Intraperitoneal Adhesions and Improved delivery of therapy in Women undergoing Surgical Staging and intraperitoneal chemotherapy for Advanced Ovarian Cancer. The purpose of this study is to determine if using Seprafilm (Sodium Hyaluronate Carboxycellulose membrane) helps prevent/reduce intra-abdominal adhesion formation, and allows better delivery of intraperitoneal chemotherapy for women with advanced ovarian cancer. Spirtos M.D., Nicola M  (702)851-4689
10.04.004 SWOG S0702: A Prospective Observational Multicenter Cohort Study to Assess The Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients with Bone Metastases Starting Zoledronic Acid Treatment. The purpose of this study is to see how often ONJ occurs in patients who are being treated with zoledronic acid during a 3 year time period after starting treatment. Ellerton M.D., John A.  (702)384-0013
10.04.002 SWOG S0919: A Phase II Study of Idarubicin and Ara-C in Combination with Pravastatin for Relapsed Acute Myelogenous Leukemia. The purpose of this study is to evaluate the effects of regular chemotherapy plus pravastatin on leukemia. Ellerton M.D., John A.  (702)384-0013
10.03.019 ECOG E1505: CIRB: A Phase III Randomized Trial Of Adjuvant Chemotherapy With or Without Bevacizumab For Patients With Completely Resected Stage IB (> or equal to 4 CM) - IIIA Non-Small Cell Lung Cancer (NSCLC) The purpose of this study is to determine if adding bevacizumab to chemotherapy improves the chance of cure for patients who have had surgery for the removal of their lung cancer. Ellerton M.D., John A.  (702)384-0013
10.03.018 ECOG E2905: CIRB: Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide (Revlimid®) Alone and in Combination with Epoetin Alfa (Procrit®) in Subjects with Low- or Intermediate-1 Risk MDS and Symptomatic Anemia. The purpose of this study is to compare how Lenalidomide affects subjects with low or intermediate-1 risk MDS and symptomatic anemia when given alone compared with when given with epoetin alfa. Ellerton M.D., John A.  (702)384-0013
10.03.015 COG AAML0631: CIRB: Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) using Arsenic Trioxide (Trisenox IND# 103,331) during Consolidation. The purpose of this study is to test the effects of reducing the amount of anthracycline chemotherapy and adding arsenic to standard APL treatment. Bernstein M.D., Jonathan  (702)384-0013
10.03.013 GOG-0261: A Randomized Phase III Trial of Paclitaxel Plus Carboplatin Versus Ifosfamide Plus Paclitaxel in Chemotherapy-Naive Patients With Newly Diagnosed Stage I-IV Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus. The purpose of this study is to compare carboplatin and paclitaxel to paclitaxel plus ifosfamide and mesna. Spirtos M.D., Nicola M  (702)851-4688
10.03.002 CALGB 90601: CIRB: A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma The purpose of this study is to compare the effects of the combination of gemcitabine and cisplatin with the combination of gemcitabine, cisplatin and bevacizumab on transitional cell carcinoma. Ellerton M.D., John A.  (702)384-0013
10.03.001 RTOG 0920: CIRB: A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PKC412) (IND # 101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age with FLT3 Mutated Acute Myeloid Leukemia (AML) The purpose of this study is to compare the effects of radiation therapy alone with radiation therapy and cetuximab on locally-advanced resected head and neck cancer. Ellerton M.D., John A.  (702)384-0013
10.02.007 ECOG E1305: CIRB: A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer. The purpose of this study is to compare the effects of the addition of Bevacizumab to the standard chemotherapy. Ellerton M.D., John A.  (702)384-0013
10.02.002 COG ACCL0731: Glutamic Acid to Decrease Vincristine Toxicity in Children with Cancer. The purpose of this study is to see if taking l-glutamic acid hydrochloride will decrease the frequency or the severity of neurotoxicity. Bernstein M.D., Jonathan  (702)384-0013
09.11.009 COG AEWS07B1: A Children's Oncology Group Protocol for Collecting and Banking Ewing Sarcoma Specimens. The purpose of this study is to collect Ewing sarcoma tumor specimens and blood and bone marrow samples from patients with these tumors. These specimens will be used by researchers to increase our knowledge about how to diagnose and treat Ewing sarcoma. Bernstein M.D., Jonathan  (702)384-0013
09.11.002 URCC UCCO08106: A Study of the Effects of Exercise on Cancer-Related Fatigue. The purpose of this study is to determine the efficacy of a home-based walking and progressive resistance exercise program from reducing cancer-related fatigue among patients during chemotherapy. Ellerton M.D., John A.  (702)384-0013
09.09.003 GOG 0252: A Phase III Clinical Trial of Bevacizumab with IV Versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma NCI-Supplied Agent(s): Bevacizumab (NSC#704865, IND #7921). The purpose of this study is to compare IV chemotherapy with two different IP treatment plans (regimens) to determine if there is a survival benefit. Spirtos M.D., Nicola M  (702)851-4687
09.09.002 GOG 0258: A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel VS. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma. The purpose of this study is to determine if radiation therapy combined with chemotherapy administered for a total of 4 cycles offers a benefit over chemotherapy alone administered over 6 cycles. Spirtos M.D., Nicola M  (702)851-4686
09.06.008 Titrated Oral Misoprostol for Labor Induction. The purpose of this study is to evaluate the safety and efficacy of Misoprostol given orally. Further to evaluate the dose based on contractions achieved will be more efficient in cervical ripening. Matsunaga-Kirgan M.D., Marsha  (702)671-2300
09.06.005 GOG 0249: A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed by Paclitaxel/Carboplatin Chemotherapy in Patients with High Risk, Early Stage Endometrial Carcinoma. The purpose of this study is to determine if treatment with vaginal cuff brachytherapy followed by three cycles of chemotherapy reduces the rate of recurrence or death when compared to pelvic radiation therapy. Spirtos M.D., Nicola M  (702)851-4685
09.05.001 GOG 0240: A Randomized Phase III Trial of Cisplatin Plus Paclitaxel with and without NCI-Supplied Bevacizumab (NSC #704865, IND#7921) Versus the Non-Platinum Doublet, Topoetecan Plus Paclitaxel, with or without NCI-Supplied Bevacizumab, In Stage IVB, Recurrent or Persistent Carcinoma of the Cervix. The purpose of this study is to compare the effectiveness, safety, and the impact on health related quality of life of cisplatin and paclitaxel, cisplatin and paclitaxel plus bevacizumab, paclitaxel and topotecan, as well as paclitaxel and topotecan plus bevacizumab in stage IVB recurrent or persistent carcinoma of the cervix. Spirtos M.D., Nicola M  (702)851-4684
09.01.006 GOG 0233/ACRIN 6671: Utility of Preoperative FDG-PET/CT and Ferumoxtran-10 MRI Scanning Prior to Primary Chemoradiation Therapy to Detect Retroperitoneal Lymph Node Metastasis in Patients with Locoregionally Advanced (IB2, IIA greater than or equal to 4 CM, IIB-IVA) Carcinoma of the Cervix. The purpose of this study is to define the utility of preoperative FDG-PET/CT and ferumoxtran-10 MRI scanning prior to primary chemoradiation therapy to detect retroperitoneal lymph node metastasis in patients with locoregionally advanced carcinoma of the cervix. Spirtos M.D., Nicola M  (702)851-4683
09.01.005 GOG 0235: A Prospective, Longitudinal Study of YKL-40 in Patients with FIGO Stage III or IV Invasive Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Undergoing Primary Chemotherapy. The purpose of this study is to measure YKL-40 in patients with ovarian cancer. Spirtos M.D., Nicola M  (702)851-4682
08.10.008 GOG 0238: A Randomized Trial of Pelvic Irradiation with or without Concurrent Weekly Cisplatin in Patients with Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus. The purpose of this study is to compare radiation therapy in combination of weekly treatment with cisplatin. Spirtos M.D., Nicola M  (702)851-4680
08.10.006 GOG 0242: A Phase II Study to Determine the Response to Second Curettage As Initial Management for Persistent Low Risk, Non-Metastatic Gestational Trophoblastic Neoplasia. The purpose of this study is to determine if a second curettage will decrease the likelihood of the need for chemo in the future. Spirtos M.D., Nicola M  (702)851-4679
08.10.001 Assessment of the Utility of Vibration Response Imaging (VRI) in the Emergency Department Setting. The purpose of this study is to correlate vibration response imaging (VRI) measurements with other standard measurements used to assess patients presenting to the emergency department with symptoms of dyspnea. Slattery M.D., David E.  (702)383-1880
08.09.003 Use of Positron Emission Tomography (PET) Scan and Detection of Positive Supraclavicular Lymph Nodes in Stage IIIc Ovarian Cancer. The purpose of this study is to identify the false positive and false negative rates in PET scan detection of positive supraclavicular lymph nodes, and to determine the incidence of positive supraclavicular lymph nodes in stage IIIc ovarian cancer. Spirtos M.D., Nicola M  (702)851-4678
08.09.002 Use of Computed Tomography (CT) Scan and Detection of Positive Supraclavicular Lymph Nodes in Stage IIIc Ovarian Cancer. The purpose of this study is to identify the false positive and false negative rates in CT scan detection of positive supraclavicular lymph nodes and to determine the incidence of positive supraclavicular lymph nodes in stage IIIc ovarian cancer. Spirtos M.D., Nicola M  (702)851-4677
08.07.008 RTOG 0436: CIRB: A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients with Esophageal Cancer who are Treated without Surgery. The purpose of this study is to compare the effects of radiation therapy and chemotherapy (paclitaxel and cisplatin) with or without the addition of cetuximab to find out which treatment is better. Ellerton M.D., John A.  (702)384-0013
08.07.005 CALGB 30607: CIRB: Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC#736511, IND#74019) as Maintenance Therapy in Non-Progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB/IV Non-Small Cell Lung Cancer. The purpose of this study is to determine whether or not giving sunitinib after chemotherapy will aim in tumor shrinkage. Ellerton M.D., John A.  (702)384-0013
08.06.006 BB-TR-2008: Beta-Blockade in Adult Critically Injured Trauma Patients. The purpose of this study is to determine the effect of mild beta-blockade on mortality and hospital resource utilization in severely injured trauma patients who remain tachycardia after adequate resuscitation. Kuhls M.D., Deborah A  (702)671-2300
08.06.001 HUD: ENTERPRISE™ Vascular Reconstruction Device and Delivery System (H060001) This HUD will be implanted in patients who need treatment with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms arising from a parent vessel with a diameter of > than or=to 2.5mm and < ="to"> Agrawal M.D., Rajneesh  (702)794-4384
08.05.004 Contraceptive Knowledge, Choices and Options among HIV + Women of Child Bearing Age in Clark County, Nevada The purpose of this study is to evaluate the birth control and pregnancy decisions of HIV positive women in Clark County, Nevada. Ezeanolue M.D., Echezona  (702)671-2231
08.04.019 COG ANBL00B1: CIRB: Neuroblastoma Biology Studies. The purpose of this study is to collect samples of tumor, blood and/or bone marrow to learn more about neuroblastoma. Bernstein M.D., Jonathan  (702)384-0013
08.04.018 COG D9902: CIRB: A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol. The purpose of this study is to identify the type of soft tissue carcinoma. Bernstein M.D., Jonathan  (702)384-0013
08.04.017 COG AALL0434: CIRB: Intensified Methotrexate, Nelarabine (Compound 506U78; IND#52611) and Augmented BFM Therapy for Children and Young Adults with Newly Diagnosed T-call Acute Lymphoblastice Leukemia (ALL). The purpose of this study is to compare the effects of two different treatment plans for patients with Intermediate Risk T-cell ALL. Bernstein M.D., Jonathan  (702)384-0013
08.04.016 COG AALL05B1: CIRB: A Children's Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Research Specimens. The purpose of this study is to collect leukemia cells and normal blood cells from patients with all that relapse and to store them for use in future research studies. Bernstein M.D., Jonathan  (702)384-0013
08.04.015 COG AREN03B2: CIRB: Renal Tumors Classification, Biology and Banking Study. The purpose of this study is to find out more information about tumor treatment. Bernstein M.D., Jonathan  (702)384-0013
08.04.014 COG AREN0321: CIRB: Treatment of High Risk Renal Tumors. The purpose of this study is to see if irinotecan and vincristine are effective in treating the renal tumor. The second regimen will look at the combination of five standard drugs compared to the currently used treatment regimens. Bernstein M.D., Jonathan  (702)384-0013
08.04.013 COG AREN0533: CIRB: Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumor. The purpose of this study is to evaluate if subjects with Wilms tumor that has spread to their lungs can be treated without having radiation therapy to their lungs. Bernstein M.D., Jonathan  (702)384-0013
08.04.012 COG AREN0532: CIRB: Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor. The purpose of this study is to evaluate the use of doxorubicin in conjunction with standard therapy in the reduction of tumor return in subjects with a high risk of tumor return. Bernstein M.D., Jonathan  (702)384-0013
08.04.005 CALGB 30610: CIRB: Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer also Receiving Cisplatin and Etoposide. The purpose of this study is to compare the effects of three different ways to give radiation therapy. Ellerton M.D., John A.  (702)384-0013
08.03.008 ECOG E4805: A Randomized Phase II Study to Determine the Effect of 2 Different Doses of AVE0005 (VEGF Trap) in Patients with Metastatic Renal Cell Carcinoma. The purpose of this study is to compare the effects of two different doses of the AVE0005 on you and your kidney cancer to see which is better and to assess the safety and side-effects of AVE0005 in patients with advanced renal cell carcinoma. Ellerton M.D., John A. D83 (702)384-0013
08.03.004 ACNS0332: CIRB Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients: A Groupwide Phase III Study. The purpose of this study is to compare the effects of carboplatin and isotretinoin on subjects with high risk medulloblastoma and to find out if one or both are better than standard therapy. Bernstein M.D., Jonathan  (702)384-0013
08.02.008 RTOG 0534: CIRB: A Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPORT) in Prostate Cancer Patients with a Rising PSA after Radical Prostatectomy. The purpose of this study is to compare the effects, good and/or bad of three treatment methods on participants and their cancer. Ellerton M.D., John A.  (702)384-0013
08.01.006 GOG 0213: A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel Alone or in Combination with Bevacizumab (NSC#704865, IND#7921) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. NCI-Supplied Agents: Bevacizumab (NSC#704865, IND#7921) The purpose of this study is to compare the combination of carboplatin, paclitaxel and bevacizumab to the standard combination of carboplatin and paclitaxel alone. Spirtos M.D., Nicola M  (702)851-4676
07.11.004 GOG 0221: Glycoprotein and Glycan Profiling in Patients with Locally Advanced Cervical Cancer (Stage IB2, IIA greater than 4CM, IIB to IVA) Undergoing Pelvic and Para-Aortic (Abdominal) Lymphadenectomy. The purpose of this study is to study three biomarkers to see if the level of any of these biomarkers is associated with how the cancer grows and spreads. Spirtos M.D., Nicola M  (702)851-4675
07.10.007 ECOG E3805: CIRB: CHAARTED: Chemo Hormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer. The purpose of this study is to determine whether giving docetaxel chemotherapy is more effective than giving it only at the time the hormonal therapy is no longer working. Ellerton M.D., John A.  (702)384-0013
07.08.004 H050001: The Wingspan Stent System and Gateway PTA Balloon Catheter (HDE) The FDA granted HUD designation January 2004 because there are no equivalent devices available for the treatment of intracranial atherosclerotic disease. Agrawal M.D., Rajneesh  (702)794-4384
07.08.003 H020002: Neuroform Microdelivery Stent System (HDE) The FDA granted a HUD designation in August 2000 because there are no equivalent devices available for the treatment of intracranial wide neck aneurysms. Agrawal M.D., Rajneesh  (702)794-4384
07.08.002 Energy Expenditure in Trauma Patients with Open Abdomen. The purpose of this study is to measure the energy expenditure of trauma patients admitted to an intensive care unit and compare measured energy expenditure with values that have been estimated using predictive equations. Kuhls M.D., Deborah A  (702)671-2300
07.06.007 CALGB 90203: CIRB: A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy In Patients with High-Risk, Clinically Localized Prostate Cancer The purpose is to determine if high risk prostate cancer pts treated w/Docetaxel and androgen deprivation therapy before surgery to remove the prostate gland and surrounding tissue have a better 3 yr. outcome compared w/cancer pts treated w/surgery alone. Ellerton M.D., John A.  (702)384-0013
06.08.004 New Therapeutic Targets for Treatment of Pre-Term Labor: Request to Obtain Samples of Pregnant Human Uterus. The purpose of this study is to find ways to prevent and treat pre-term labor through tissue samples from uteruses from healthy term or near-term pregnancies. Matsunaga-Kirgan M.D., Marsha  (702)671-2300
06.06.004 Outpatient Misoprostol in Managing Post-Term Pregnancies The purpose of this study is to determine if outpatient misoprostol given at the routine post term antepartum testing visits would be an effective, safe, economical and convenient method to get the fetus delivered earlier with less post term risks, and to make labor induction more effective. Matsunaga-Kirgan M.D., Marsha  (702)671-2300
06.03.003 HDE: H990014- Enterra® Therapy Gastric Stimulation System In March of 2000, the FDA gave approval of a Humanitarian Device Exemption (HDE) of a Humanitarian Use Device (HUD) of Enterra Therapy. Enterra Therapy is indicated for the treatment of patients with long term, uncontrolled (not helped by medication) nausea and vomiting from Gastroparesis of diabetic or idiopathic (unknown) origin. HUDs are medical devices approved by the FDA for the treatment of medical conditions affecting less than 4,000 patients per year. In granting HDE approval for a HUD, the FDA mainly looks at the safety of the device, rather than how well it helps. Although there is data that suggests the use of the Enterra Therapy system probably helps patients' symptoms, more studies are needed to prove this. This is not a research study. Federal regulations regarding HDE's state that each hospital's IRB must approve the use of this type of device at their hospital. Barber M.D., Annabel E.  (702)671-2298
05.11.006 GOG0207: A Randomized, Double-Blind Phase II Trial of Celecoxib, a COX-2 Inhibitor, in the Treatment of Patients with Cervical Intraepithelial Neoplasia (CIN 2/3 or 3) (IND #69,656). The purpose of this study is to determine the efficacy of Celecoxib to induce complete remission of CIN 3 or partial regression to CIN 1 as evaluated in the post-treatment excisional biopsy. Spirtos M.D., Nicola M  (702)851-4674
05.11.003 RTOG0524: A Phase I/II Trial of a Combination of Paclitaxel and Trastuzumab with Daily Irradiation or Paclitaxel alone with Daily Irradiation following Transurethral Surgery for Non-Cystectomy Candidates with Muscle-Invasive Bladder Cancer The purpose of this study is to determine the acute toxicity from chemoradiotherapy including paclitaxel plus trastuzumab and irradiation in non-cystectomy patients with or without her2/neu overexpression. Ellerton M.D., John A.  (702)384-0013
05.10.004 GOG 0218: CIRB Facilitated: A Phase III Trial Of Carboplatin And Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC #704865, IND #7921) Followed By Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent And Extended Bevacizumab, In Women With Newly Diagnosed, Previously Untreated, Suboptimal Advanced Stage Epithelial Ovarian and Primary Peritoneal Cancer The purpose of this study is to determine if the addition of 5 concurrent cycles of bevacizumab to 6 cycles of standard therapy increases the duration of progression-free survival when compared to 6 cycles of standard therapy alone in women with newly diagnosed stage III and stage IV, epithelial ovarian, peritoneal primary or fallopian tube cancer. Spirtos M.D., Nicola M  (702)851-4673
05.08.008 GOG 0210: Molecular Staging Study of Endometrial Carcinoma The purpose of this study is to improve outcome and/or quality of life for patients with endometrial cancer. Spirtos M.D., Nicola M  (702)851-4672
05.06.005 CALGB 50303: CIRB Phase III Randomized Study of R-CHOP V. Dose-Adjusted Epoch-R With Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas The purpose of this study is to compare the event-free survival of R-CHOP versus DA-EPOCH-R chemotherapy in untreated CD20+ diffuse large B-cell lymphomas and to develop a molecular predictor of outcome of R-CHOP and DA-EPOCH-R chemotherapy using molecular profiling. Ellerton M.D., John A.  (702)384-0013
05.04.009 NSABP B-39/RTOG 0413: CIRB Oversight: A Randomized Phase III Trial of Conventional Whole Breast Irradiation (WBI) vs. Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer The purpose of this study is to determine whether partial breast irradiation (PBI) limited to the region of the tumor bed following lumpectomy provides equivalent local tumor control in the breast compared to conventional whole breast irradiation (WBI) in the local management of early stage breast cancer. Ellerton M.D., John A.  (702)384-0013
00.01.002 CALGB 9862: Molecular Genetic Features of Acute Lymphoblastic Leukemia The purpose of this study is to perform quantitative PCR using leukemia specific markers in diagnostic bone marrow specimens of patients with newly diagnosed APL and ALL and to correlative pre-treatment copy number with other biologic and molecular features, clinical response, and treatment outcome. Ellerton M.D., John A.  (702)384-0013
98.01.008 CALGB 9665:  Tissue Bank - CALGB Leukemia (Companion Study to CALGB 9251) The purpose of this study is to collect and store specimens from every newly diagnosed patient with acute or chronic leukemia or myelodysplastic syndrome (MDS) who are entered on a CALGB protocol for previously untreated patients. Ellerton M.D., John A.  (702)384-0013
84.06.001 CALGB 8461: Cytogenetic Studies in Acute Leukemia The purpose of this study is to determine the incidence of specific less common primary as well as common secondary chromosome abnormalities in adult AML, ALL, and MDS. Ellerton M.D., John A.  (702)384-0013
0899 GOG 0212: CIRB: A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel of XYOTAXJ (CT-2103) (IND 70177) vs. No Treatment Until Documented Relapse in Women with Advanced Ovarian or Primary Peritoneal Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane The purpose of this study is to determine whether CT-2103 or paclitaxel, administered to women with advanced ovarian, primary peritoneal or fallopian tube cancer who have attained a clinically-defined complete response to primary platinum/taxane-based chemotherapy will reduce the death rate, compared to re-treatment at the time of documented disease progression. Spirtos M.D., Nicola M  (702)851-4681