Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00006008
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
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 acute lymphoblastic leukemia.
- Detailed Description
OBJECTIVES:
* Determine the complete remission rate of patients with relapsed or refractory acute lymphoblastic leukemia treated with arsenic trioxide.
* Determine the toxic effects of induction arsenic trioxide in this patient population.
OUTLINE: Patients are stratified according to administration schedule of arsenic trioxide (5 days a week vs 7 days a week).
Patients receive arsenic trioxide IV over 1 hour daily until bone marrow blasts are less than 5% or for a maximum of 60 days. Beginning 3-6 weeks after induction, patients achieving a complete remission receive arsenic trioxide IV over 1 hour daily either 5 days or 7 days a week for 25 days. Subsequent consolidation courses are given with 4 week treatment-free intervals between courses. Treatment continues for a maximum of 5 consolidation courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 13-40 patients will be accrued for this study within 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (71)
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Cancer Center and Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
Veterans Affairs Medical Center - Palo Alto
🇺🇸Palo Alto, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
CCOP - Colorado Cancer Research Program, Inc.
🇺🇸Denver, Colorado, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
Veterans Affairs Medical Center - Gainsville
🇺🇸Gainesville, Florida, United States
Veterans Affairs Medical Center - Miami
🇺🇸Miami, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Veterans Affairs Medical Center - Tampa (Haley)
🇺🇸Tampa, Florida, United States
Scroll for more (61 remaining)CCOP - Scottsdale Oncology Program🇺🇸Scottsdale, Arizona, United States