Phase II Study of Dolastatin-10 in Patients With Advanced Renal Cell Carcinoma
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.
Interventional
Primary Purpose: Treatment
Henry C. Pitot, MD
Study Chair
Mayo Clinic
United States: Food and Drug Administration
CDR0000067094
NCT00003914
August 1999
May 2009
Name | Location |
---|---|
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Mayo Clinic Jacksonville | Jacksonville, Florida 32224 |