Arsenic Trioxide in Treating Patients With Refractory or Recurrent Acute Promyelocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT00008697|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: arsenic trioxide||Phase 1 Phase 2|
OUTLINE: This is a dose-escalation study.
Patients receive arsenic trioxide IV over 2 hours daily for 28 days followed by a 14 day rest period. Patients may receive up to 3 courses of treatment.
Dose escalation continues in cohorts of 3-6 patients until the maximum tolerated dose (MTD) or minimum effective dose (MED) is determined. The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity. The MED is defined as the dose at which 4 of 6 patients achieve a complete cytogenetic or molecular response. After the MTD or MED is determined, an additional 20 patients are enrolled at this dose level.
Patients are followed monthly for 6 months and every three months for an additional 1.5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase I/II Trial of Infusional Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia|
|Study Start Date :||November 1998|
|Actual Primary Completion Date :||April 2002|
|Actual Study Completion Date :||April 2002|
Experimental: Phase 1
Cohort 1 Arsenic trioxide = 0.1 mg/kg/day x 28 days with 14 day rest for 3 cycles (each cycle = 6 weeks)
Cohort 2 Arsenic trioxide = 0.15 mg/kg/day x 28 days with 14 day rest for 3 cycles (each cycle = 6 weeks)
Cohort 3 Arsenic trioxide = 0.20 mg/kg/day x 28 days with 14 day rest for 3 cycles (each cycle = 6 weeks)
Cohort 4 Arsenic trioxide = 0.25 mg/kg/day x 28 days with 14 day rest for 3 cycles (each cycle = 6 weeks)
Cohort 5 Arsenic trioxide = 0.30 mg/kg/day x 28 days with 14 day rest for 3 cycles (each cycle = 6 weeks)
|Drug: arsenic trioxide|
Experimental: Phase 2
Arsenic trioxide = MTD found in Phase 1 mg/kg/day x 28 days with 14 day rest for 3 cycles (each cycle = 6 weeks)
|Drug: arsenic trioxide|
- Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) or minimum effective dose (MED) [ Time Frame: 6 weeks ]
- Efficacy (response and survival) at the MTD - Phase 2 only [ Time Frame: 18 weeks ]
- Acute and chronic toxicities [ Time Frame: 18 weeks ]
- Evaluation of the pharmacokinetics and their correlation with toxicities and response [ Time Frame: 18 weeks ]
- Evaluation of PML/RARA and PML protein redistribution and degradation following treatment and their correlation with response [ Time Frame: 18 weeks ]
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): NCT00008697
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||John F. DiPersio, MD, PhD||Washington University School of Medicine|