NCT00093483

Arsenic Trioxide, Cytarabine, and Idarubicin in Treating Patients With Acute Myeloid Leukemia

Arsenic Trioxide, High-Dose Cytarabine and Idarubicin Induction Therapy in Previously Untreated de Novo and Secondary Adult Acute Myeloid Leukemia Patients < 60 Years Old - A Phase I Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, cytarabine, and idarubicin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide when given together with cytarabine and idarubicin in treating patients with acute myeloid leukemia.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose and/or biologically effective dose of arsenic trioxide followed by high-dose cytarabine and idarubicin in patients with previously untreated de novo or secondary acute myeloid leukemia. OUTLINE: This is a dose-escalation study of arsenic trioxide. Patients are stratified according to timing of accrual (before November 2002 vs since November 2002). Patients receive arsenic trioxide IV over 1 hour on day 1 followed by high-dose cytarabine IV over 1 hour every 12 hours on days 1-6 and idarubicin IV over 30 minutes on days 2-4 (immediately after doses 3, 5 and 7 of cytarabine). Patients also receive filgrastim (G-CSF) subcutaneously beginning 12 hours after the last dose of chemotherapy and continuing until blood counts recover. Cohorts of 3-6 patients receive escalating doses of arsenic trioxide until the maximum tolerated dose (MTD), current dose used for myelodysplastic syndromes or acute promyelocytic leukemia, or biologically effective dose is reached. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. The biologically effective dose is defined as the dose at which 3 patients with constitutive STAT3 activity have the activity negated after the first dose of arsenic trioxide. PROJECTED ACCRUAL: A maximum of 40 patients (6 for stratum I \[accrued before November 2002\] and 34 for stratum II \[accrued since November 2002\] will be accrued for this study within 3 years.

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim	Subcutaneously beginning 12 hours after the last dose of chemotherapy and continuing until blood counts recover.
DRUG	arsenic trioxide	IV over 1 hour on day 1
DRUG	cytarabine	IV over 1 hour every 12 hours on days 1-6
DRUG	idarubicin	IV over 30 minutes on days 2-4 (immediately after doses 3, 5 and 7 of cytarabine).

Timeline

• Start date: 2002-04-01
• Primary completion: 2009-11-01
• Completion: 2009-12-01
• First posted: 2004-10-08
• Last updated: 2014-01-13

Locations

1 site across 1 country: United States