RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill leukemia cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation and interleukin-2 in treating patients who have acute leukemia.

Condition	Treatment or Intervention	Phase
adult acute lymphoblastic leukemia adult acute myeloid leukemia childhood acute lymphoblastic leukemia childhood acute myeloid leukemia secondary acute myeloid leukemia	Drug: busulfan  Drug: cyclophosphamide  Drug: etoposide  Drug: filgrastim  Drug: interleukin-2  Drug: melphalan  Procedure: biological response modifier therapy  Procedure: bone marrow ablation with stem cell support  Procedure: chemotherapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy  Procedure: interleukin therapy  Procedure: peripheral blood stem cell transplantation	Phase II

Further Study Details: 

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.

Genders Eligible for Study:  Both

Criteria

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

New York
      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States

Study chairs or principal investigators

Charles S. Hesdorffer, MD,  Study Chair,  Columbia Presbyterian Medical Center   

Study ID Numbers:  CDR0000068386; CPMC-IRB-8872; CPMC-CAMP-27; NCI-G00-1889
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  January 6, 2001
ClinicalTrials.gov Identifier:  NCT00008190
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08