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Phase II Study of Arsenic Trioxide, NSC 706363, in Relapsed of Refractory Chronic Myelogenous Leukemia

Phase 2
Not Enrolling

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Trial Information

Phase II Study of Arsenic Trioxide, NSC 706363, in Relapsed of Refractory Chronic Myelogenous Leukemia

OBJECTIVES: I. Determine the antileukemic efficacy of arsenic trioxide in patients with
relapsed and/or refractory, chronic, accelerated, or blastic phase chronic myelogenous
leukemia. II. Determine the pattern of clinical adverse experience in this patient
population administered this drug.

OUTLINE: Patients are stratified according to disease stage (chronic phase vs accelerated
phase or blastic phase). Patients receive arsenic trioxide IV over 1 hour on consecutive
days or weekdays only for a total of 25 days followed by 3-5 weeks of rest. Treatment
continues for a maximum of 6 courses in the absence of unacceptable toxicity or disease
progression. Patients with responding disease are followed at least monthly.

PROJECTED ACCRUAL: A total of 10-27 patients will be accrued for the chronic phase stratum
of this study within 2 years. A total of 17-37 patients will be accrued for the accelerated
and blastic phases stratum of this study within 2 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Chronic myelogenous leukemia (CML) confirmed by: Cytogenetic
testing demonstrating presence of t(9:22) OR RT-PCR demonstrating presence of BCR/ABL
rearrangement Chronic phase Blast count less than 15% OR Accelerated phase defined by 1 or
more of the following: Blast count greater than 15% but less than 30% Blast count and
promyelocytes greater than 30% Basophils greater than 20% Thrombocytopenia less than
100,000/mm3 not related to therapy Cytogenetic clonal evolution (13) OR Blastic phase
Blast count greater than 30% OR Evidence of extramedullary blasts Relapse from or failure
to achieve a major cytogenetic response to at least 1 course of standard anti-CML therapy
including interferon alfa or cytotoxic chemotherapy Must have failed adequate trial of
interferon alfa unless intolerance to or contraindication to interferon alfa Not eligible
for allogeneic stem cell transplant

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no
greater than 1.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5
times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception during and for 4 months after study No active serious infections
that are not controlled by antibiotics

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 4 weeks
since prior interferon alfa Chemotherapy: See Disease Characteristics At least 4 weeks
since prior chemotherapy (1 day for hydroxyurea) No other concurrent chemotherapy
Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not
specified Other: No other concurrent investigational agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David A. Scheinberg, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

March 2004

Related Keywords:

  • Leukemia
  • relapsing chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive



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