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Phase II Study of Dolastatin-10 in Patients With Advanced Renal Cell Carcinoma (NCT00003914)

National Cancer Institute (NCI)
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.
  • Drug: dolastatin 10
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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.

    3 locations

    United States (3)
    • Mayo Clinic Scottsdale
      Not specified
      Scottsdale, Arizona, United States, 85259
    • Mayo Clinic Jacksonville
      Not specified
      Jacksonville, Florida, United States, 32224
    • Mayo Clinic Cancer Center
      Not specified
      Rochester, Minnesota, United States, 55905
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 July, 1999
    Updated:
    09 May, 2011
    Participants:
    30
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