Kidney Cancer Clinical Trial
Official title:
Phase II Study of Dolastatin-10 in Patients With Advanced Renal Cell Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients
with advanced kidney cancer.
OBJECTIVES: I. Evaluate the response rate to dolastatin 10 in patients with advanced renal
cell carcinoma. II. Describe the toxicities of this regimen in this patient population. III.
Assess the development of peripheral neuropathy in this patient population using this
regimen. IV. Assess a limited sampling of pharmacokinetics and correlate with toxicity in
these patients.
OUTLINE: Patients receive dolastatin 10 IV every 3 weeks. Treatment continues for at least 4
courses in the absence of disease progression or unacceptable toxicity. Patients with
documented complete response receive an additional 2 courses, and may receive retreatment at
the time of progression at the discretion of the investigator. Patients are followed every 3
months for 3 years.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study over 4-15
months.
;
Primary Purpose: Treatment
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