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Sponsored by: |
Loyola University |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003126 |
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of interleukin-2 with no further therapy in treating patients with stage III or stage IV kidney cancer.
Condition | Intervention | Phase |
---|---|---|
Kidney Cancer |
Drug: aldesleukin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Controlled Phase III Adjuvant Trial of High-Dose Bolus IL-2 in Patients With High-Risk Renal Cell Carcinoma |
Estimated Enrollment: | 68 |
Study Start Date: | June 1997 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease classification (T3b (N0) or N1 (T1-3b) vs T3c or T4 (N0-1) vs N2 or N3 disease (T1-4) vs M1 disease resected to no evaluable disease). Within 3-12 weeks after radical nephrectomy and/or resection of metastases, patients are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study within 3 years.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven high-risk renal cell carcinoma that has been completely resected within the past 12 weeks
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Cancer Center and Beckman Research Institute, City of Hope | |
Duarte, California, United States, 91010-3000 | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095-1781 | |
Summit Medical Center | |
Oakland, California, United States, 94609 | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90033-0804 | |
United States, Illinois | |
Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
United States, Indiana | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202-5289 | |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 | |
University of Michigan Comprehensive Cancer Center | |
Ann Arbor, Michigan, United States, 48109-0752 | |
United States, New Hampshire | |
Norris Cotton Cancer Center | |
Lebanon, New Hampshire, United States, 03756-0002 | |
United States, New York | |
Our Lady of Mercy Medical Center | |
Bronx, New York, United States, 10466 | |
United States, North Carolina | |
Carolinas Medical Center | |
Charlotte, North Carolina, United States, 28232-2861 | |
United States, Oregon | |
Earle A. Chiles Research Institute at Providence Portland Medical Center | |
Portland, Oregon, United States, 97213-2967 | |
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232-6838 | |
United States, Texas | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78284-7811 |
Study Chair: | Joseph I. Clark, MD | Loyola University |
Study ID Numbers: | CDR0000065887, CWG-LU-8520, NCI-V97-1351 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003126 |
Health Authority: | United States: Federal Government |
stage III renal cell cancer stage IV renal cell cancer |
Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Carcinoma Aldesleukin Urologic Diseases |
Interleukin-2 Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Neoplasms Anti-HIV Agents Neoplasms by Site Neoplasms by Histologic Type |
Anti-Retroviral Agents Antineoplastic Agents Therapeutic Uses Antiviral Agents Pharmacologic Actions |