Kidney Cancer Clinical Trial
Official title:
A RANDOMIZED PHASE II TRIAL OF INTERFERON ALPHA-2A WITH AND WITHOUT 13-CIS RETINOIC ACID IN PATIENTS WITH PROGRESSIVE MEASURABLE METASTATIC RENAL CELL CARCINOMA. Amendment Protocol: Extension to a Randomized Phase III Trial
RATIONALE: Interferon alfa may interfere with the growth of the cancer cells and slow the
growth of kidney cancer. Isotretinoin may help kidney cancer cells develop into normal
cells. It is not yet known whether interferon alfa plus isotretinoin is more effective than
interferon alfa alone for kidney cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or
without isotretinoin in treating patients who have metastatic kidney cancer.
OBJECTIVES: I. Assess the response rate and response duration of interferon alfa with vs
without isotretinoin in patients with bidimensionally measurable progressive metastases from
renal cell cancer. II. Assess the toxic effects of these regimens in this patients
population. III. Determine the overall survival of this patient population treated with
these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center. Patients are randomized to one of two treatment arms. Arm I: Patients
receive interferon alfa subcutaneously daily. Arm II: Patients receive interferon alfa as in
arm I plus oral isotretinoin daily. Treatment continues for up to 1 year in the absence of
disease progression or unacceptable toxicity. Patients are followed until death.
PROJECTED ACCRUAL: A total of 296 patients will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Treatment
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