Laromustine, Daunorubicin, and Cytarabine in Treating Patients With Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as laromustine, daunorubicin, and cytarabine, 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 I/II trial is studying the side effects and best dose of laromustine when given together with daunorubicin and cytarabine in treating patients with acute myeloid leukemia.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Paoli-Calmettes
• Treatments: Amsacrine; Busulfan; Cytarabine; Daunorubicin; Melphalan; Mitoxantrone

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of acute myeloid leukemia (AML)

• Untreated disease

• No promyelocytic AML

• Unfavorable prognosis, defined as at least one of the following:

• Cytogenetic abnormalities including -5/5q-, -7/7q-, 3q, 11q23, t(6;9), and complex abnormalities (≥ 3 clonal abnormalities), excluding t(9;11)

• Baseline hyperleukocytosis ≥ 100 g/L or progression of leukocytosis or extra-medullary localizations despite treatment with hydroxyurea

• No AML with favorable or intermediate prognosis

• No AML secondary to myelodysplastic syndrome diagnosed within the past 3 months or myeloproliferative syndrome

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Total bilirubin < 35 μmol/L

• Transaminases < 2.5 times upper limit of normal in the absence of leukemia-related abnormalities

• Creatinine < 170 μmol/L OR creatinine clearance ≥ 50 mL/min in the absence of leukemia-related abnormalities

• Not pregnant or nursing

• Normal cardiac function by LVEF (echographic ≥ 40% or isotopic ≥ 50%)

• Affiliated with a social security system

• No uncontrolled or severe cardiovascular disease, including any of the following:

• Myocardial infarction within the past 3 months

• Cardiac insufficiency

• Uncontrolled arrhythmia

• No other active cancer within the past year except for basal cell carcinoma of the skin or epithelioma in situ of the cervix

• No patients deprived of freedom or under guardianship (including temporary guardianship)

• No psychological, familial, geographical, or social situations that preclude follow-up

• No other contraindications to study treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Prior hydroxyurea allowed

• No concurrent disulfiram

• No concurrent participation in another study with an experimental drug