Leukemia Clinical Trial
Official title:
A Pilot Study of Arsenic Trioxide-Based Consolidation Therapy for the Primary Treatment of Acute Promyelocytic Leukemia
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer
cells, either by killing the cells or by stopping them from dividing. Giving more than one
drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy works in
treating patients with acute promyelocytic leukemia.
OBJECTIVES:
- Determine, preliminarily, the safety of incorporating arsenic trioxide (ATO) into
cytarabine and daunorubicin hydrochloride-based consolidation therapy followed by
tretinoin maintenance therapy in patients receiving induction tretinoin and
daunorubicin hydrochloride with acute promyelocytic leukemia (APL) induced into
remission with tretinoin and daunorubicin hydrochloride.
- Determine, preliminarily, the efficacy of this strategy in inducing and maintaining
molecular remissions in patients treated with this regimen.
OUTLINE: This is a pilot, multicenter study.
- Induction therapy: Patients receive oral tretinoin twice daily on days 1-60 and
daunorubicin hydrochloride IV on days 4, 6, and 8. Patients are evaluated between days
60-67 and proceed to consolidation therapy.
- Consolidation therapy: Patients receive cytarabine IV continuously on days 1-3,
daunorubicin hydrochloride IV on days 1-3, and arsenic trioxide IV over 1-2 hours once
daily, 5 days a week, beginning on day 8 and continuing for 6 weeks. Patients with
clinical and/or cytogenic, but not molecular, remission receive additional arsenic
trioxide once daily, 5 days a week, for 30 doses (6 weeks). Patients achieving clinical
and molecular remission after completion of 6 or 12 weeks of arsenic trioxide proceed
to maintenance therapy.
- Maintenance therapy: Patients receive oral tretinoin once daily on days 1-15. Treatment
repeats every 3 months for 8 courses (2 years).
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
;
Primary Purpose: Treatment
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