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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Given IV
M D Anderson Cancer Center
Houston, Texas, United States
Rate of progression-free events
Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests.
Time frame: 6 months
Objective response rate
Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests.
Time frame: Up to 3 years
Survival
Analyzed using Kaplan Meier curves and Cox proportional hazards models.
Time frame: Up to 3 years
Time to disease progression
Analyzed using Kaplan Meier curves and Cox proportional hazards.
Time frame: Up to 3 years
Time to treatment failure
Analyzed using Kaplan Meier curves and Cox proportional hazards.
Time frame: Up to 3 years
Duration of response
Analyzed using Kaplan Meier curves and Cox proportional hazards.
Time frame: Up to 3 years
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