SU5416 and Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer

Phase 2

Completed

• Conditions: Kidney Cancer

• Registration Number: NCT00006384
• Lead Sponsor: City of Hope Medical Center

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2000-10-04
• Study Start: 2000-11
• Study First Submitted QC: 2003-12-23
• Study First Posted: 2003-12-24
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-18
• Last Update Posted: 2011-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

Cancer Center and Beckman Research Institute, City of Hope; 🇺🇸 Duarte, California, United States

University of California Davis Cancer Center; 🇺🇸 Sacramento, California, United States

USC/Norris Comprehensive Cancer Center and Hospital; 🇺🇸 Los Angeles, California, United States