Kidney Cancer Clinical Trial
Official title:
Interferon Alpha In Combination With Thalidomide In The Treatment Of Metastatic Renal Cell Carcinoma A Randomized Phase II Study
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Thalidomide may
stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if
interferon alfa is more effective with or without thalidomide in treating metastatic kidney
cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of interferon alfa with or
without thalidomide in treating patients who have metastatic kidney cancer.
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.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Treatment
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