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Dolastatin 10 in Treating Patients With Advanced Kidney Cancer

Phase 2
Completed
Conditions
Kidney Cancer
Registration Number
NCT00003914
Lead Sponsor
Mayo Clinic
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

Mayo Clinic Scottsdale

🇺🇸

Scottsdale, Arizona, United States

Mayo Clinic Cancer Center

🇺🇸

Rochester, Minnesota, United States

Mayo Clinic Jacksonville

🇺🇸

Jacksonville, Florida, United States

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