Arsenic Trioxide in Treating Patients With Relapsed or Refractory Chronic Myelogenous Leukemia
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|ClinicalTrials.gov Identifier: NCT00005618|
Recruitment Status : Completed
First Posted : April 2, 2004
Last Update Posted : June 21, 2013
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 or disease||Intervention/treatment||Phase|
|Leukemia||Drug: arsenic trioxide||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Study of Arsenic Trioxide, NSC 706363, in Relapsed of Refractory Chronic Myelogenous Leukemia|
|Study Start Date :||February 2000|
|Actual Study Completion Date :||March 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005618
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||David A. Scheinberg, MD, PhD||Memorial Sloan Kettering Cancer Center|