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Phase II Trial of Arsenic Trioxide (NSC #706363) in Patients With Advanced Renal Cell Carcinoma

Phase 2
Not Enrolling
Kidney Cancer

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Trial Information

Phase II Trial of Arsenic Trioxide (NSC #706363) in Patients With Advanced Renal Cell Carcinoma

OBJECTIVES: I. Evaluate the efficacy of arsenic trioxide in patients with metastatic renal
cell cancer. II. Determine the safety of this regimen in this patient population.

OUTLINE: Patients receive arsenic trioxide IV over 1-4 hours daily for 5 days. Treatment
continues every 4 weeks for a maximum of 12 courses in the absence of disease progression or
unacceptable toxicity. Patients are followed for at least 1 month.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-19

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert J. Motzer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 2000

Completion Date:

July 2001

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021