Busulfan, Etoposide, and Total-Body Irradiation Followed by Autologous Stem Cell Transplant and Aldesleukin in Treating Patients With Acute Myeloid Leukemia in First Remission

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving chemotherapy before an autologous 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 and/or bone marrow and stored. More chemotherapy and radiation therapy is given to 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. Giving aldesleukin after transplant may help keep cancer cells from coming back after transplant.

PURPOSE: This phase II trial is studying the side effects and how well giving busulfan and etoposide together with total-body irradiation followed by autologous stem cell transplant and aldesleukin works in treating patients with acute myeloid leukemia in first remission.

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

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aldesleukin; Busulfan; Cytarabine; Etoposide; Etoposide phosphate; Idarubicin

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of acute myeloid leukemia (AML)

• FAB types M0-2 and M4-M7

• No M3 disease

• In first complete hematological remission as confirmed by marrow aspiration and biopsy

• No cytogenetic abnormality in the remission marrow

• In complete remission for less than 6 months

• Patients who have been in complete remission for more than 6 months may be eligible upon approval of the principal investigator

• No prior myeloproliferative disorder (e.g., chronic myeloid leukemia, myelofibrosis, essential thrombocytosis, or polycythemia vera)

• No prior myelodysplasia or secondary leukemia

PATIENT CHARACTERISTICS:

• FEV_1 > 60%

• DLCO > 50%

• Cardiac ejection fraction ≥ 50%

• Creatinine clearance > 60 mL/min

• No severe chronic medical or psychological illness that, in the judgement of the principal investigator, would jeopardize the ability of the patient to tolerate aggressive chemotherapy

• No HIV positivity

• Not pregnant

• Negative pregnancy test

PRIOR CONCURRENT THERAPY:

• Prior consolidation therapy allowed

• No concurrent use the following medications during aldesleukin therapy :

• Corticosteroids (including blood product "pre-meds")

• Pentoxifylline

• IV or intrathecal methotrexate

• IV immunoglobulin

• Other cytokines or growth factors