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

Phase 2
18 Years
Not Enrolling
Kidney Cancer

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Trial Information

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

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma considered
incurable by surgery and not amenable to radiation therapy with curative intent Locally
advanced disease OR Locally recurrent disease OR Metastatic disease No transitional cell
carcinoma Measurable disease No CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: AST less than 3 times upper limit
of normal (ULN) Bilirubin normal Renal: Creatinine less than 1.5 times ULN Cardiovascular:
No New York Heart Association class III or IV heart disease Metabolic: Oral intake at
least 1,200 calories per day Other: Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception No uncontrolled infection No known
seizure disorder No other malignancy within the past 5 years except nonmelanoma skin
cancer or carcinoma in situ of the cervix No other medical or psychiatric condition that
would interfere with compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy
No concurrent immunomodulating agents Chemotherapy: No prior chemotherapy for renal cell
carcinoma No other concurrent cytostatic or cytotoxic therapy Endocrine therapy: At least
4 weeks since prior hormonal therapy No concurrent hormonal agents Radiotherapy: See
Disease Characteristics At least 3 weeks since prior radiotherapy No prior radiotherapy to
greater than 15% of bone marrow No concurrent radiotherapy Surgery: See Disease

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Henry C. Pitot, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

August 1999

Completion Date:

May 2009

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Mayo Clinic Jacksonville Jacksonville, Florida  32224