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

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
Characteristics