Arsenic Trioxide in Treating Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT00006090|
Recruitment Status : Withdrawn (No enrollment.)
First Posted : March 25, 2004
Last Update Posted : October 10, 2012
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor 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 chronic lymphocytic leukemia that has relapsed or has not responded to treatment with fludarabine.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: arsenic trioxide||Phase 2|
OBJECTIVES: I. Determine the clinical efficacy and safety of arsenic trioxide in patients with chronic lymphocytic leukemia (CLL) that is refractory to fludarabine or in relapse. II. Determine the pattern of clinical adverse experience in these patients when treated with this regimen. III. Evaluate the effects of this drug on cytokines, apoptosis, and angiogenesis in these patients.
OUTLINE: Patients receive arsenic trioxide IV over 2 hours on days 1-15 OR on days 1-5, 8-12, and 15-19. Courses repeat with 2 to 5 week intervals between courses for 10-12 courses (about 1 year) in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 6 months for the second year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Arsenic Trioxide (NSC #706363) Therapy for Fludarabine Refractory or Relapsed Chronic Lymphocytic Leukemia|
|Study Start Date :||June 2000|
|Actual Primary Completion Date :||October 2001|
|Actual Study Completion Date :||October 2001|
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): NCT00006090
|Study Chair:||Deborah A. Thomas, MD||M.D. Anderson Cancer Center|