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Phase I Study of Arsenic Trioxide

Phase 1
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of Arsenic Trioxide

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of arsenic trioxide in adult and
pediatric patients with advanced solid tumors. II. Determine the pattern of clinical adverse
experience of arsenic trioxide in this patient population. III. Evaluate evidence of
clinical responsiveness to this treatment regimen.

OUTLINE: This is a dose escalation, open label study. Patients are stratified by age
(pediatric vs adult). Patients receive arsenic trioxide IV over 1-2 hours once daily for 3
consecutive days then once weekly for 5 weeks. Patients with stable or responding disease
receive additional courses of therapy every 8 weeks for up to 1 year in the absence of
disease progression or unacceptable toxicity. Patients receive escalating doses of arsenic
trioxide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which 2 or more patients out of 6 experience dose limiting toxicity.
Patients are followed for at least 1 month after treatment.

PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor Relapsed from or
resistant to at least 1 course of standard anticancer therapy AND/OR Lack of standard
therapy that is known to be beneficial in the underlying disease

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-3 Life expectancy:
Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine
no greater than 2.5 times ULN Other: Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception during and for at least 4 months
following study No active serious infections that are not controlled by antibiotics

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See
Disease Characteristics No other concurrent chemotherapy Endocrine therapy: See Disease
Characteristics Radiotherapy: See Disease Characteristics No concurrent radiotherapy
Surgery: See Disease Characteristics Other: No other concurrent investigational agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Steven Soignet, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 1998

Completion Date:

August 2000

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • unspecified childhood solid tumor, protocol specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms



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