Interferon Alpha In Combination With Thalidomide In The Treatment Of Metastatic Renal Cell Carcinoma A Randomized Phase II Study

OBJECTIVES:

• Determine the safety of interferon alfa and thalidomide in patients with metastatic renal cell carcinoma.
• Compare the relative toxicity of interferon alfa with or without thalidomide in these patients.
• Assess the antiangiogenic effect of thalidomide by monitoring the angiogenesis-associated factors in these patients.
• Compare, in a preliminary manner, the efficacy of interferon alfa with or without thalidomide in these patients.
• Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.

• Arm I: Patients receive interferon alfa subcutaneously 3 times a week and oral thalidomide once daily for 12 weeks.
• Arm II: Patients receive interferon alfa only as in arm I. Treatment in both arms repeats every 12 weeks in the absence of disease progression or unacceptable toxicity. Patients in arm II who develop disease progression discontinue interferon alfa and receive thalidomide only as in arm I.

Quality of life is assessed at baseline and then every 3 weeks during each study course.