Phase II Trial of SU5416 and Interferon Alfa 2B in Unresectable or Metastatic Renal Cell Carcinoma
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.
Interventional
Primary Purpose: Treatment
Primo N. Lara, MD
Study Chair
University of California, Davis
United States: Federal Government
00041
NCT00006384
November 2000
February 2007
Name | Location |
---|---|
Cancer Center and Beckman Research Institute, City of Hope | Duarte, California 91010-3000 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
University of California Davis Cancer Center | Sacramento, California 95817 |