Arsenic Trioxide in Treating Young Patients With Refractory Leukemia or Lymphoma
- Conditions
- LeukemiaLymphoma
- Registration Number
- NCT00020111
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide in treating young patients with leukemia or lymphoma.
- Detailed Description
OBJECTIVES:
* Determine the toxic effects of arsenic trioxide in pediatric patients with refractory leukemia or lymphoma.
* Determine the maximum tolerated dose of this drug in this patient population.
* Determine the plasma pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to disease (acute promyelocytic leukemia \[APL\] vs non-APL).
* Stratum I (APL patients): Patients receive standard-dose arsenic trioxide IV over 2 hours daily 5 days a week for 4 weeks. Treatment continues every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
* Stratum II (Non-APL patients): Cohorts of 3-6 patients receive escalating doses of arsenic trioxide (according to the stratum 1 schedule above) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with arsenic trioxide at the recommended phase II dose.
Leukemia patients in both strata without progressive disease who have not achieved complete remission after the first 20 doses may continue to receive arsenic trioxide for 2 additional weeks.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A maximum of 18 patients will be accrued for stratum I of this study within 2-3 years. A total of 3-30 patients will be accrued for stratum II of this study within 1-2 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 (52)
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Lucile Packard Children's Hospital at Stanford University Medical Center
🇺🇸Palo Alto, California, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
County of Los Angeles Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Scroll for more (42 remaining)Arkansas Cancer Research Center at University of Arkansas for Medical Sciences🇺🇸Little Rock, Arkansas, United States