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Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer Clinical research trials and Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer. Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer  Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer
Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer
For Condition: recurrent renal cell cancer,stage 4 renal cell cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: RATIONALE: Carboxyamidotriazole may stop the growth of kidney cancer by stopping blood flow to the tumor. PURPOSE: Randomized phase II trial to study the effectiveness of carboxyamidotriazole in treating patients who have metastatic kidney cancer.
Details: OBJECTIVES: I. Determine the toxicity and disease-stabilizing effect of carboxyamidotriazole in patients with metastatic renal cell carcinoma. II. Determine the objective response rate in patients treated with this drug. PROTOCOL OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to time from diagnosis of metastatic disease to study entry (fewer than 24 months vs 24 months or more). Patients receive oral carboxyamidotriazole (CAI) daily for 4 weeks. Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity. Patients with stable disease are randomized to one of two treatment arms. Arm I: Patients receive oral CAI as above. Arm II: Patients receive a placebo. Treatment repeats every 4 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression are unblinded and those on placebo begin oral CAI as above. Patients are followed every 6 months. PROJECTED ACCRUAL: A maximum of 335 patients will be accrued for this study within 15-25 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed renal cell carcinoma - Metastatic or unresectable disease - Documented disease progression, even after nephrectomy At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques OR - At least 10 mm by spiral CT scan - The following lesions are not considered measurable: *Bone lesions *Leptomeningeal disease *Ascites *Pleural/pericardial effusion *Abdominal masses not confirmed and followed by imaging *Cystic lesions --Prior/Concurrent Therapy-- Biologic therapy: - At least 4 weeks since prior immunotherapy - No prior carboxyamidotriazole - No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) - Concurrent epoetin alfa allowed Chemotherapy: - At least 4 weeks since prior chemotherapy - No concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy except steroids for adrenal failure or hormones for conditions not related to disease (e.g., insulin for diabetes) Radiotherapy: - At least 4 weeks since prior radiotherapy - No concurrent palliative radiotherapy Surgery: - See Disease Characteristics - At least 4 weeks since prior surgery --Patient Characteristics-- Age: 18 and over Performance status: CTC 0-2 Life expectancy: Not specified Hematopoietic: - WBC at least 2,000/mm3 - Platelet count at least 75,000/mm3 Hepatic: - Bilirubin no greater than upper limit of normal (ULN) - AST no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No baseline neuropathy or cerebellar dysfunction greater than grade 1
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WalterStadler, Study Chair, Cancer and Leukemia Group B
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233-1996
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Schneider Children's Hospital at North Shore
Manhasset, New York, 11030
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Additional Information:
Study ID Numbers: CDR0000068317; CLB-69901
Study Start Date: October 2000
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006486
Other Stage 4 Renal Cell Cancer Studies:
1. Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer
2. Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Metastatic Kidney Cancer
3. Interleukin-2, Interferon alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer
4. Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer
5. Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer
Related Studies:
Other stage 4 renal cell cancer Clinical Trials
Other Florida Clinical Trials
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Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer
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