Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia

OBJECTIVES:

• Determine the efficacy of busulfan, cyclophosphamide, and etoposide followed by autologous peripheral blood stem cell transplantation and interleukin-2 in patients with high-risk acute leukemia.
• Determine the efficacy of immunomodulatory therapies in terms of relapse-free survival of these patients treated with this regimen.
• Determine the hematopoietic reconstitution, relapse, and survival of these patients treated with this regimen.
• Determine the toxicity of this regimen in these patients.

OUTLINE: Following a course of mobilization chemotherapy, patients receive priming therapy comprising filgrastim (G-CSF) and interleukin-2 through the completion of leukapheresis. Patients then receive oral busulfan 4 times daily on days -8 through -5, cyclophosphamide IV continuously on days -4 and -3, and etoposide IV over 2 hours on day -4. For patients unable to receive cyclophosphamide and etoposide, melphalan IV is administered instead on days -3 and -2. Autologous peripheral blood stem cells (PBSC) are reinfused on day 0.

Patients then receive G-CSF daily beginning on day 0 and continuing until blood counts recover followed by interleukin-2 subcutaneously daily beginning at the completion of G-CSF therapy and continuing for 6 months.

Patients are followed weekly for 1 month and then monthly thereafter.

PROJECTED ACCRUAL: A total of 19-25 patients will be accrued for this study within 3-5 years.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed acute leukemia

• High-risk due to any of the following:

• Cytogenetic abnormalities involving 5q, 7q, 8q, 11q23, or t(9;22)
• WBC greater than 100,000/mm3
• Prior myelodysplastic syndrome
• Complete remission (CR) lasting less than 12 months
• No favorable cytogenetic parameters (e.g., t(15;17), inv16, or t(8;21))
• CR following standard anti-leukemic therapy confirmed by bone marrow evaluation

• Second and third CR allowed
• Ineligible for higher priority national or institutional study or allogeneic peripheral blood stem cell transplantation

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Bilirubin less than 1.5 times normal
• SGOT or SGPT less than 1.5 times normal

Renal:

• Creatinine less than 1.5 times normal

Cardiovascular:

• LVEF at least 45% if receiving cyclophosphamide
• Normal electrocardiogram OR
• Approval by cardiologist

Pulmonary:

• DLCO less than 60% predicted OR
• Approval by pulmonologist

Other:

• Not pregnant or nursing
• No concurrent illness that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified