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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00018941 |
Purpose
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. It is not yet known which regimen of interleukin-2 is most effective for kidney cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of interleukin-2 in treating patients who have metastatic kidney cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Biological: aldesleukin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase III Randomized Study of Intravenous Low Dose Versus Intravenous High Dose Versus Subcutaneous Interleukin-2 for Metastatic Renal Cell Carcinoma |
| Study Start Date: | April 1991 |
OBJECTIVES: I. Determine the response rate and overall survival of patients with metastatic renal cell carcinoma treated with either low-dose or high-dose intravenous interleukin-2 (IL-2) or subcutaneous IL-2. II. Compare the toxic effects of these 3 regimens in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to presence of renal tumor (yes vs no).
Patients are randomized to one of three treatment arms. Arm I: Patients receive low dose interleukin-2 (IL-2) IV every 8 hours for up to 15 doses. Treatment repeats in 7-10 days for one complete course. Arm II: Patients receive high dose IL-2 IV every 8 hours for up to 15 doses. Treatment repeats in 7-10 days for one complete course. Arm III: Patients receive IL-2 subcutaneously daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive an additional complete course of therapy.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven, metastatic renal cell carcinoma with measurable disease No more than 25% of liver replaced with tumor No CNS involvement or major nerve compression allowed
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 3 months Hematopoietic: Not specified Hepatic: Bilirubin less than 2.0 mg/dL AST and ALT no greater than 3 times normal Renal: Creatinine less than 1.6 mg/dL Cardiovascular: Normal EKG Normal thallium stress test (required of patients 50 years of age and older or as clinically indicated) Pulmonary: FEV1 and VC greater than 65% of predicted (pulmonary function screening required of patients with significant smoking history or suspicion of pulmonary disease) Other: No second malignancy, except: Basal cell skin cancer Carcinoma in situ of the cervix No significant psychiatric disease that would preclude consent or treatment No systemic infection No coagulation disorders or bleeding Not pregnant HIV negative
PRIOR CONCURRENT THERAPY: No prior therapy within 28 days Biologic therapy: No prior interleukin-2 Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent steroids
Contacts and Locations More Information
| Study ID Numbers: | CDR0000076799, NCI-91-C-0094, NCI-T91-0053N |
| Study First Received: | July 11, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00018941 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV renal cell cancer recurrent renal cell cancer |
|
Anti-Infective Agents Urinary Tract Neoplasm Kidney Cancer Anti-HIV Agents Urogenital Neoplasms Urologic Neoplasms Antiviral Agents Recurrence Carcinoma Aldesleukin Renal Cancer |
Anti-Retroviral Agents Urologic Diseases Analgesics, Non-Narcotic Interleukin-2 Kidney Neoplasms Carcinoma, Renal Cell Peripheral Nervous System Agents Analgesics Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
|
Anti-Infective Agents Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Neoplasms by Site Urologic Diseases Anti-Retroviral Agents Kidney Neoplasms Sensory System Agents Therapeutic Uses Kidney Diseases Analgesics Neoplasms by Histologic Type |
Anti-HIV Agents Antiviral Agents Pharmacologic Actions Carcinoma Neoplasms Aldesleukin Interleukin-2 Analgesics, Non-Narcotic Carcinoma, Renal Cell Peripheral Nervous System Agents Adenocarcinoma Central Nervous System Agents Neoplasms, Glandular and Epithelial |
