Arsenic Trioxide in Treating Patients With Relapsed or Refractory Chronic Myelogenous Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005618
First received: May 2, 2000
Last updated: June 20, 2013
Last verified: October 2001
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer 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 relapsed or refractory chronic myelogenous leukemia.


Condition Intervention Phase
Leukemia
Drug: arsenic trioxide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Arsenic Trioxide, NSC 706363, in Relapsed of Refractory Chronic Myelogenous Leukemia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2000
Study Completion Date: March 2004
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005618

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: David A. Scheinberg, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005618     History of Changes
Other Study ID Numbers: CDR0000067755, MSKCC-99076A, NCI-190
Study First Received: May 2, 2000
Last Updated: June 20, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
relapsing chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Arsenic trioxide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014