Arsenic Trioxide in Treating Patients With Advanced Hematologic Cancer
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|ClinicalTrials.gov Identifier: NCT00003395|
Recruitment Status : Completed
First Posted : August 16, 2004
Last Update Posted : June 25, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of arsenic trioxide in treating patients who have advanced hematologic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm||Drug: arsenic trioxide||Phase 1|
OBJECTIVES: I. Develop a safe, weight-based, extended-dosing regimen of arsenic trioxide suitable for outpatient therapy in patients with advanced hematologic cancers. II. Determine the pattern of clinical adverse experience in patients treated with this drug. III. Evaluate evidence of clinical responsiveness that may provide leads for further testing in patients treated with this drug.
OUTLINE: This is a dose-escalation study. Patients receive arsenic trioxide IV over 1-4 hours on days 1-25. Courses repeat every 3-5 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 4-6 patients receive escalating doses of arsenic trioxide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity. Patients are followed for 1 month.
PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Dose-Ranging Study of Arsenic Trioxide in Advanced Hematologic Cancers|
|Study Start Date :||April 1998|
|Actual Primary Completion Date :||March 2000|
|Actual Study Completion Date :||March 2000|
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): NCT00003395
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Steven Soignet, MD||Memorial Sloan Kettering Cancer Center|