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 6-hydroxymethylacylfulvene in treating
patients with metastatic kidney cancer.
OBJECTIVES: I. Evaluate the efficacy of 6-hydroxymethylacylfulvene (HMAF) in patients with
metastatic renal cell carcinoma. II. Investigate the safety of HMAF given to this patient
OUTLINE: Patients receive 6-hydroxymethylacylfulvene intravenously for 5 minutes every day
for 5 consecutive days. Treatment is repeated every 28 days in the absence of disease
progression or unacceptable toxicity. Patients are followed after every 2 treatment courses.
PROJECTED ACCRUAL: Approximately 12-37 patients will be accrued for this study within 6-19
DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma and evidence of
metastatic disease Bidimensionally measurable disease No active brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Greater than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute
neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin
within normal range ALT/AST no greater than 2.5 times upper limit of normal (ULN) Renal:
Creatinine within 1.5 times ULN AND Creatinine clearance at least 50 mL/min Other: Not
pregnant or lactating Fertile patients must use effective contraception No prior
malignancy within 5 years and at low risk for recurrence Must have undergone potentially
curative therapy for prior malignancy
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since biological therapy and
recovered Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: At least 4
weeks since hormone therapy and recovered Radiotherapy: At least 4 weeks since
radiotherapy Surgery: At least 4 weeks since major surgery