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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Arsenic Trioxide; Cytarabine; Idarubicin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed de novo or secondary acute myeloid leukemia with ≥ 20% blasts AND at least 1 of the following characteristics*:

• Auer rods

• Peroxidase or sudan black positive blasts

• Chloroacetate esterase-positive or diffusely non-specific esterase-positive blasts

• Presence of a myeloid immunophenotype by multiparameter flow cytometry, including expression of one or more myeloid markers (CD13, CD33) on blasts NOTE: *Megakaryocytic leukemia can be diagnosed by the detection of platelet antigens (e.g. factor VIII, glycoprotein Ib or IIb/IIIa) using monoclonal antibodies or the presence of ultrastructural platelet peroxidase

• No acute promyelocytic leukemia

• No Philadelphia-chromosome positive chronic myeloid leukemia

• Prior hematologic disorders, including myelodysplastic syndromes, aplastic anemia, paroxysmal nocturnal hemoglobinuria, and myeloproliferative disorders allowed

PATIENT CHARACTERISTICS:

Age

• 18 to 59

Performance status

• Not specified

Life expectancy

• More than 4 weeks

Hematopoietic

• Not specified

Hepatic

• Bilirubin ≤ 2 times normal*

• SGOT ≤ 2 times normal*

• Alkaline phosphatase ≤ 2 times normal* NOTE: *Unless abnormalities are directly attributable to leukemia

Renal

• Creatinine ≤ 1.5 times normal* NOTE: *Unless abnormalities are directly attributable to leukemia

Cardiovascular

• Cardiac ejection fraction ≥ 45%*

• Absolute QT interval ≤ 460 msec with potassium > 4.0 mEq/L and magnesium > 1.8 mg/dL

• No myocardial infarction within the past 6 months

• No uncontrolled symptomatic congestive heart failure

• No angina pectoris

• No multifocal cardiac arrythmias

• No other severe cardiovascular disease NOTE: *Unless abnormalities are directly attributable to leukemia

Other

• No serious medical or psychiatric illness that would preclude informed consent or limit survival to < 4 weeks

• No uncontrolled diabetes mellitus

• No other concurrent active malignancy

• No known hypersensitivity to E. coli-derived drug preparations

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for acute leukemia, except hydroxyurea to control white blood cell counts

• Prior chemotherapy for an antecedent malignancy or other medical condition allowed

Endocrine therapy

• Not specified

Radiotherapy

• Prior radiotherapy for an antecedent malignancy or other medical condition allowed

Surgery

• Not specified