Kidney Cancer Clinical Trial
Official title:
Phase II Trial of SU5416 and Interferon Alfa 2B in Unresectable or Metastatic Renal Cell Carcinoma
RATIONALE: SU5416 may stop the growth of kidney cancer by stopping blood flow to the tumor.
Interferon alfa-2b may interfere with the growth of the cancer cells. Combining interferon
alfa-2b with SU5416 may be an effective treatment for kidney cancer.
PURPOSE: Phase II trial to study the effectiveness of combining SU5416 and interferon
alfa-2b in treating patients who have unresectable or metastatic kidney cancer.
OBJECTIVES: I. Determine the efficacy and toxicity of SU5416 combined with interferon
alfa-2b in patients with unresectable or metastatic renal cell carcinoma.
OUTLINE: This is a multicenter study. Patients receive SU5416 IV over 30-60 minutes twice
weekly and interferon alfa-2b subcutaneously every 12 hours daily. Treatment continues every
6 weeks for a minimum of 2 courses. Patients who achieve partial response or stable disease
after completion of course 2 receive additional courses in the absence of disease
progression or unacceptable toxicity. Patients who achieve complete response may receive
additional courses, at the discretion of the protocol investigator, in the absence of
disease progression or unacceptable toxicity. Patients with disease progression are allowed
to stay on the study until any measurable lesion increases to over 100% of baseline
measurement. Patients are followed for survival.
PROJECTED ACCRUAL: A total of 20-31 patients will be accrued for this study within 12-18
months.
;
Primary Purpose: Treatment
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