Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia

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

Summary

RATIONALE: Giving combination chemotherapy before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood or bone marrow and stored. More chemotherapy or radiation therapy is given prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. Interleukin-2 may stimulate the patient's white blood cells to kill cancer cells.

PURPOSE: This randomized phase III trial is studying two different regimens of combination chemotherapy, interleukin-2, and peripheral stem cell transplant and comparing them to see how well they work in treating patients with acute myeloid leukemia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Collaborator: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Treatments: Aldesleukin; Busulfan; Cyclophosphamide; Cytarabine; Daunorubicin; Etoposide

Criteria

DISEASE CHARACTERISTICS:

• First randomization:

• Untreated newly diagnosed acute myeloid leukemia (AML)

• At least 30% blasts in bone marrow

• All cytological types of AML except acute promyelocytic leukemia (M3)

• No blast crisis of chronic myelogenous leukemia

• No leukemias supervening after other myeloproliferative disease

• No leukemias supervening after overt myelodysplastic disorders (e.g., refractory anemia with excess blasts) for more than 6 months duration

• Second randomization:

• Must have achieved complete remission with full hematologic recovery following consolidation treatment

• No HLA identical family donor

• Not eligible for allograft

• No high risk patient (under age 40) for whom an unrelated bone marrow donor has been found within 8 weeks of beginning consolidation treatment

PATIENT CHARACTERISTICS:

Age:

• 15 to 60

Performance status:

• WHO 0-3 (first randomization)

• WHO 0-2 (second randomization)

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 3 times upper limit of normal (ULN)

Renal:

• Creatinine no greater than 3 times ULN

Cardiovascular:

• No severe heart failure requiring diuretics

• Ejection fraction at least 50%

Other:

• First randomization:

• No other progressive malignant disease except the following:

• Secondary acute leukemias following curatively treated Hodgkin's disease (even if treated with anthracyclines)

• Other curatively treated malignancies

• Secondary leukemias following other exposure to alkylating agents or radiotherapy for other reason

• No uncontrolled infection

• No severe concurrent neurologic or psychiatric disease

• No psychological, familial, sociological, or geographical condition that could preclude compliance

• Second randomization:

• No nonmalignant systemic illness that would increase risk of participation in study

• No uncontrolled infection

• No other progressive malignant disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for AML except hydroxyurea

• Less than 7 days of prior hydroxyurea

Endocrine therapy:

• No more than 7 days of prior corticosteroid therapy for AML

Radiotherapy:

• No prior radiotherapy for AML

Surgery:

• Not specified