Tretinoin and Arsenic Trioxide With or Without Idarubicin in Treating Patients With Acute Promyelocytic Leukemia

• Status: Terminated
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Tretinoin may help cancer cells become more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as arsenic trioxide and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving tretinoin together with arsenic trioxide with or without idarubicin may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving tretinoin together with arsenic trioxide with or without idarubicin works in treating patients with acute promyelocytic leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Cephalon; National Cancer Institute (NCI)
• Treatments: Arsenic Trioxide; Idarubicin; Tretinoin

Criteria

DISEASE CHARACTERISTICS:

• Morphologic diagnosis of acute promyelocytic leukemia (APL), confirmed by one of the following:

• Demonstration of t(15;17) using conventional cytogenetics or fluorescence in situ hybridization (FISH)

• Positive PML-RARα transcript by reverse transcriptase-polymerase chain reaction (RT-PCR) assay

• Patients with CNS involvement by APL are eligible

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%

• Creatinine ≤ 2.0 mg/dL or creatinine clearance > 60 mL/min

• Bilirubin < 2.0 mg/dL (unless attributed to Gilbert disease)

• Alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)

• AST and ALT ≤ 2.5 ULN

• LVEF ≥ 50% on echocardiogram or MUGA scan

• QTc ≤ 500 msec on baseline ECG

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for ≥ 4 months after the completion of study treatment

• No active serious infections not controlled by antibiotics

• No other concurrent active malignancy requiring immediate therapy

• No clinically significant cardiac disease (New York Heart Association class III or IV heart disease), including chronic arrhythmias

• No pulmonary disease

• No other serious or life-threatening condition deemed unacceptable by the principal investigator

PRIOR CONCURRENT THERAPY:

• No prior treatment for APL