A Phase II Study Using Low Dose Subcutaneous IL-2, Vinblastine and GM-CSF in the Treatment of Metastatic Renal Cell Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven inoperable, metastatic, or recurrent renal
cell carcinoma Measurable or evaluable disease No brain metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-2 Life expectancy: At
least 3 months Hematopoietic: Neutrophil count greater than 1,500/mm3 Platelet count
greater than 100,000/mm3 Hepatic: Liver enzymes less than 3 (5 if known liver metastases)
times institutional normal Renal: Creatinine less than 1.5 mg/dL Cardiovascular: Adequate
cardiac function No unstable angina No significant coronary artery disease No heart
failure with New York Heart Association classification III or IV Pulmonary: No evidence of
pulmonary disease (documented normal DLCO and PFT) Other: No prior malignancy except:
Nonmelanoma skin cancer Carcinoma in situ of any kind No pregnant or lactating Fertile
patients must use adequate contraception Normal thyroid functions as evidenced by normal
T4 and TSH

PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior biologic therapy At least
4 weeks since prior biologic therapy Chemotherapy: No more than 1 prior chemotherapy At
least 4 weeks since prior chemotherapy Endocrine therapy: No more than 1 prior hormonal
therapy At least 4 weeks since prior hormonal therapy Radiotherapy: At least 4 weeks since
prior radiation therapy No prior radiation therapy if entire tumor was within radiation
field Surgery: Not specified