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
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
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
Nina Aass, MD
Norwegian Radium Hospital
United States: Federal Government