SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment

Stage IV Renal Cell Cancer Clinical Trial

Official title: Phase II Study of SU5416 (NSC 696819) for Patients With Progressive Metastatic Renal Cancer Failing Prior Biologic Therapy or 5-Fluorouracil Containing Regimens

Status Terminated

Clinical Trial Summary

Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic kidney cancer that has not responded to previous therapy with interleukin-2. SU5416 may stop the growth of kidney cancer by stopping blood flow to the tumor

Clinical Trial Description

OBJECTIVES:

I. Determine the clinical activity of SU5416 in patients with progressive metastatic renal cancer failing prior biologic therapy or fluorouracil-containing regimens.

II. Determine the changes in tumor perfusion in patients treated with this regimen.

III. Determine the time to progression and survival in patients treated with this regimen.

OUTLINE:

Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues every 6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive an additional 6 months of therapy after achieving CR.

Patients are followed every 3 months. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Recurrent Renal Cell Cancer
• Stage IV Renal Cell Cancer

• NCT number: NCT00009919
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Terminated
• Phase: Phase 2
• Start date: December 2000