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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00006384
Study type Interventional
Source City of Hope Medical Center
Contact
Status Completed
Phase Phase 2
Start date November 2000
Completion date February 2007

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