Overview

6-Hydroxymethylacylfulvene in Treating Patients With Metastatic Kidney Cancer

Status:
Completed
Trial end date:
2004-08-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Irofulven
Criteria
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