Overview

Arsenic Trioxide in Treating Patients With Metastatic Kidney Cancer

Status:
Completed
Trial end date:
2001-07-01
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 arsenic trioxide in treating patients who have metastatic kidney cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Arsenic Trioxide
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell cancer
Bidimensionally measurable disease No brain metastases

PATIENT CHARACTERISTICS: Age: Not specified 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 normal ALT
or AST no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine no greater
than 1.5 times ULN (no greater than 1.95 mg/dL at MSKCC) Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception during and for 4
months after study No other prior malignancy unless curatively treated and disease free for
the past 5 years and considered low risk for recurrence

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy
and recovered No concurrent biologic therapy Chemotherapy: At least 4 weeks since prior
cytotoxic chemotherapy and recovered No other concurrent cytotoxic chemotherapy Endocrine
therapy: At least 4 weeks since prior hormonal therapy and recovered No concurrent hormonal
therapy Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy
Surgery: At least 4 weeks since prior major surgery