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.

Condition	Treatment or Intervention	Phase
Stage IV Renal Cell Cancer recurrent renal cell cancer	Drug: dolastatin 10	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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 Characteristics

--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

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

Study chairs or principal investigators

Henry Clement Pitot,  Study Chair,  Mayo Clinic Cancer Center   

Study ID Numbers:  CDR0000067094; MAYO-975002; NCI-T98-0024
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003914
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08