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Advanced Renal Cell Carcinoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Advanced Renal Cell Carcinoma conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Advanced Renal Cell Carcinoma Clinical research trials and Advanced Renal Cell Carcinoma health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Advanced Renal Cell Carcinoma. Advanced Renal Cell Carcinoma Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Advanced Renal Cell Carcinoma clinical trial. Participants oftentimes recieve the most expert healthcare available for their Advanced Renal Cell Carcinoma condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Advanced Renal Cell Carcinoma  Advanced Renal Cell Carcinoma
Advanced Renal Cell Carcinoma
For Condition: Carcinoma, Renal Cell,Kidney Neoplasms
Status: Recruiting
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: The primary objective of this study is efficacy. The primary efficacy endpoint of this study is a comparison of the overall survival of subjects treated with CCI-779, administered IV once weekly and the combination of CCI-779, administered IV once weekly with IFN alfa (SC TIW), compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced RCC. The secondary objectives of this study are safety, health outcomes, and additional efficacy endpoints. The secondary efficacy endpoints of this study are an evaluation of the following endpoints in subjects treated with CCI-779, administered IV once weekly and the combination of CCI-779, administered IV once weekly with IFN alfa (SC TIW), compared with subjects treated with IFN alfa (SC TIW) alone: progression-free survival (PFS), response rate (complete response [CR] and partial response [PR]), clinical benefit rate (CR/PR/stable disease [SD]), the duration of overall response, time to treatment failure (TTF), and health outcomes measurements. In addition, subject responses across all 3 treatment arms will be evaluated based on screening tumor expression of proteins involved in AKT-mTor pathway (i.e., Akt phosphorylation, PTEN expression). This study will evaluate the safety of subjects treated with CCI-779 and CCI-779 given in combination with IFN alfa compared with subjects treated with IFN alfa alone.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - This study will be conducted in subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC who have not received prior systemic therapy for their disease. - Subjects must have at least 3 of the following 5 prognostic factors indicating a poor prognosis: - 1.) < 1 year from time of initial RCC diagnosis to randomization - 2.) Karnofsky performance status of 70 - 3.) Hemoglobin less than the lower limit of normal - 4.) Corrected calcium > 10 mg/dL (corrected calcium = total calcium - 0.707 [albumin - 3.4 g/dL]. If a laboratory reports total calcium in millimoles per liter [mmol/L], results should be converted to milligrams per deciliter [mg/dL] using 0.249 as conversion factor) - 5.) Lactate dehydrogenase > 1.5 times the upper limit of normal (ULN) - Subjects must have a Karnofsky performance status 70. - Subject must have at least 1 measurable lesion that can be accurately measured in at least 1 dimension with the longest diameter 10 mm when measured by spiral computerized tomography (CT, 5-mm slice thickness contiguous) or 20 mm when measured by conventional CT (10-mm slice thickness contiguous) [Lesion must be 2 times the size of the slice thickness per Response Evaluation Criteria in Solid Tumors (RECIST)]. - Age >= 18 years. - Absolute neutrophil count (ANC) 1.5 x 109/L (1500 cells/mm3), platelet count 100 x 109/L (100,000 cells/ mm3), hemoglobin 8.0 g/dL (5.0 mmol/L). - Adequate renal function (serum creatinine 1.5 times the ULN). - Adequate hepatic function (bilirubin  1.5 times the ULN, AST 3 times the ULN [ 5 times the ULN if liver metastases are present]). - Fasting serum cholesterol 350 mg/dL (9.0 mmol/L), triglycerides 400 mg/dL (4.56 mmol/L). - Subjects receiving cytochrome P450 (CYP) 3A4 inducers or inhibitors must be on stable doses for at least 1 week prior to randomization. - Life expectancy of at least 8 weeks. - Signed and dated written informed consent form. Exclusion Criteria: - Subjects with central nervous system (CNS) metastases. Subjects with a prior history of CNS metastases will be eligible if the screening magnetic resonance imaging (MRI)/CT (with contrast) indicates no residual disease. - Prior anticancer therapy for RCC. - Prior investigational therapy/agents within 4 weeks of randomization. - History of other prior malignancy in past 5 years, other than basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ. - Not recovered from prior surgery and/or surgery or radiation therapy within 4 weeks of randomization. - Immunocompromised subjects, including subjects known to be human immunodeficiency virus (HIV) positive, hepatitis B positive, or hepatitis C positive. - Active infection or serious intercurrent illness. - Presence of unstable angina or myocardial infarction within the previous 6 months, use of ongoing maintenance therapy for life-threatening arrhythmia, known pulmonary hypertension, or pneumonitis. - Pregnant or nursing women, women who are of childbearing potential who are not using an effective contraceptive method, or men with partners of childbearing potential who are not using an effective contraceptive method. Agree to use effective contraceptive methods, must continue for 3 months after the last dose of CCI-779. A woman of childbearing potential is defined as a woman who is biologically capable of becoming pregnant. - Any other major illness that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in this study. - Known hypersensitivity to any of the components in the CCI-779 infusion or IFN alfa product or other medical reasons for not being able to receive adequate premedication (for example, antihistamine or anti-inflammatory agents).
Total Enrollment:
Location and Contact Information:
Boca Raton Comprehensive Cancer Center *Recruiting*
Boca Raton, Florida, 33428
United States
Recruiting Israel Wiznitzer 561-883-7600
Hematology-Oncology Centers of the Northern Rockies *Recruiting*
Billings, Montana, 59101
United States
Recruiting Patrick Cobb 406-238-6962
Kansas City Oncology and Hematology Group *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Kelly Pendergrass 816-333-1326
Ohio State University *Recruiting*
Columbus, Ohio, 43210
United States
Recruiting J. Monk III 614-293-8396
Seattle Cancer Care Alliance *Recruiting*
Seattle, Washington, 98109-1023
United States
Recruiting John Thompson 206-288-1195
Hematology - Oncology Assoc. of Northern NJ, PA *Recruiting*
Morristown, New Jersey, 07962
United States
Recruiting Steven Papish 973-538-5210
Duke University Medical Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Jared Gollob 919-668-3979
McGuire VA Medical Center *Recruiting*
Richmond, Virginia, 23249
United States
Recruiting Unyime Nseyo 804-675-5409
Medical Consultants, Ltd. *Recruiting*
Milwaukee, Wisconsin, 53215
United States
Recruiting John Hanson 414-385-3086
New York Medical College *Recruiting*
Valhalla, New York, 10595
United States
Recruiting Hoo Chun 914-493-7514
Washington University School of Medicine *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Joel Picus 314-747-1367
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Theodore Logan 317-274-3515
Medical Consultants, P.C., c/o Ball Cancer Center *Recruiting*
Muncie, Indiana, 47303
United States
Recruiting Hazim Rimawi 765-281-2030
University of Rochester Cancer Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Deepak Sahasrabudhe 585-275-4797
Midwest Hematology Oncology Consultants, Ltd. *Recruiting*
St. Louis, Missouri, 63136
United States
Recruiting Mark Woodson 314-355-5597
Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting John Ellerton 702-384-0013
University of Arkansas For Medical Science *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Rajesh Shaw 501-686-8511
Huntsman Cancer Institute at the University of Utah *Recruiting*
Salt Lake City, Utah, 84112
United States
Recruiting Wolfram Samlowski 801-581-8935
C. R. Wood Cancer Center *Recruiting*
Glen Falls, New York, 12801
United States
Recruiting Orlando Martelo 518-926-6646
Jackson Oncology Associates, PLLC *Recruiting*
Jackson, Mississippi, 39202
United States
Recruiting Bobby Graham 601-974-5600
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Robert Amato 713-798-8720
Georgetown University Medical Center *Recruiting*
Washington D.C., District of Columbia, 20007
United States
Recruiting Asim Amin 202-444-7129
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231-1000
United States
Recruiting Michael Carducci 410-614-3977
San Francisco Oncology Associates *Recruiting*
San Francisco, California, 94115
United States
Recruiting David Minor 415-885-8600
Wilshire Oncology Medical Group, Inc. *Recruiting*
La Verne, California, 91750
United States
Recruiting Richard Jr. 909-596-5333
The Center for Hematology-Oncology *Recruiting*
Boca Raton, Florida, 33486
United States
Recruiting Alan Koletsky 561-416-8869
University of Miami *Recruiting*
Miami, Florida, 33136
United States
Recruiting Pasquale Benedetto 305-243-4909
Medical Oncology and Hematology, P.C. *Recruiting*
New Haven, Connecticut, 06510
United States
Recruiting Eric Bleickardt 203-789-2050
Great Falls Clinic *Recruiting*
Great Falls, Montana, 59405
United States
Recruiting Thomas Warr 406-452-6657
Rush Presyterian St. Luke's Medical Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Kevin Conlon 312-563-2315
Baptist Regional Cancer Center *Recruiting*
Knoxville, Tennessee, 37920
United States
Recruiting Tracy Dobbs 865-632-5717
Joe Arrington Cancer Research and Treatment Center *Recruiting*
Lubbock, Texas, 79410
United States
Recruiting Jose Figueroa 806-725-8000
Hope Center *Recruiting*
Terre Haute, Indiana, 47802
United States
Recruiting Ashis Chakrabarti 812-234-0098
University of Oklahoma *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-271-4022
Charleston Hematology-Oncology, P.A. *Recruiting*
Charleston, South Carolina, 29403
United States
Recruiting George Geils 843-577-6957
Carle Clinic Association *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Ronnie Luyun 217-383-3010
Pacific Coast Hematology/Oncology Medical Group, Inc. *Recruiting*
Fountain Valley, California, 92708
United States
Recruiting Glen Justice 714-751-2600
SouthWest Cancer Care *Recruiting*
Poway, California, 92064
United States
Recruiting Michael Kosmo 858-451-7066
Cleveland Clinic Foundation *Recruiting*
Cleveland, Ohio, 44195-0001
United States
Recruiting Ronald Bukowski 216-444-6825
Sharp Health Care *Recruiting*
San Diego, California, 92123
United States
Recruiting Nayyar Siddique 858-939-5062
Ochsner Clinic Foundation *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting David Oubre 504-842-3910
Yakima Regional Cancer Care Center *Recruiting*
Yakima, Washington, 98902
United States
Recruiting Thomas Boyd 509-225-2448
Virginia Mason Medical Center *Recruiting*
Seattle, Washington, 98101
United States
Recruiting Jacqueline Vuky 206-223-6193
Michiana Hematology-Oncology, P.C. *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Robin Zon 574-234-5123
LSU Health Sciences Center *Recruiting*
Shreveport, Louisiana, 71103
United States
Recruiting Glenn Mills 318-675-4756
Penn State - Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033
United States
Recruiting Harold Harvey 717-531-8870
Northwestern Carolina Hematology Oncology, PA *Recruiting*
Hickory, North Carolina, 28602
United States
Recruiting Piyapong Vongkovit 828-324-9550
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111
United States
Recruiting Gary Hudes 215-728-3889
Vanderbilt University Medical Center *Recruiting*
Nashville, Tennessee, 37232
United States
Recruiting Jeffrey Sosman 615-322-4967
UCLA Division of Hematology/Oncology *Recruiting*
Los Angeles, California, 90024-2828
United States
Recruiting Robert Figlin 310-825-5788
Western Pennsylvania Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15224
United States
Recruiting John Lister 412-578-1605
University of Louisville *Recruiting*
Louisville, Kentucky, 40202
United States
Recruiting Damian Laber 502-562-6041
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Yoo-Joung Ko 617-667-1406
Summit Medical Group *Recruiting*
Summit, New Jersey, 07901
United States
Recruiting Michael Wax 908-273-4300
Department of Veterans Affairs *Recruiting*
East Orange, New Jersey, 07018
United States
Recruiting Basil Kasimis 973-395-7809
Providence Portland Medical Center *Recruiting*
Portland, Oregon, 97213
United States
Recruiting Brendan Curti 503-215-5696
Additional Information:
Study ID Numbers: 3066K1-304-WW;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065468
Other Kidney Neoplasms Studies:
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2. EPO906 Therapy in Patients with Advanced Kidney Cancer
3. Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
4. A Phase I Study of Continuous Intravenous Infusion of PSC 833 and Vinblastine in Patients with Metastatic Renal Cancer
5. Advanced Renal Cell Carcinoma
Related Studies:
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Advanced Renal Cell Carcinoma
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