Everolimus, Cytarabine, and Daunorubicin in Treating Patients With Relapsed Acute Myeloid Leukemia

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

Summary

RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Everolimus may help cytarabine and daunorubicin work better by making cancer cells more sensitive to chemotherapy. Giving everolimus together with cytarabine and daunorubicin may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with cytarabine and daunorubicin in treating patients with relapsed acute myeloid leukemia.

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

Details

• Lead Sponsor: Institut de Recherche Clinique sur les Cancers et le Sang
• Treatments: Cytarabine; Daunorubicin; Everolimus; Sirolimus

Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

• Diagnosis of de novo or secondary acute myeloid leukemia meeting the following criterion:

• Relapse > 1 year after obtaining complete remission (any prior treatment allowed)

Exclusion criteria:

• Philadelphia chromosome-positive disease in blast crisis

• FAB M3, M6, or M7 disease

PATIENT CHARACTERISTICS:

Inclusion criteria:

• Life expectancy ≥ 4 weeks

• Transaminases ≤ 5 times normal

• Creatinine ≤ 2 times normal

• Bilirubin ≤ 3 times normal (except if visceral involvement present)

• Alkaline phosphatase or gamma-glutamyltransferase ≤ 5 times normal

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients of must use effective contraception during and for ≥ 28 days after completion of study therapy

Exclusion criteria:

• FEV1 < 30%

• Active uncontrolled or viral pulmonary infection

• Serious psychiatric disorders not related to leukemia or any condition that would prohibit comprehension of the study

• HIV-positive

• Other concurrent malignancy except noninvasive skin cancer or carcinoma in situ

• Patients who are incarcerated or under supervision or trusteeship

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

• See Disease Characteristics

Exclusion criteria:

• Prior experimental medication within the past 4 weeks