High Dose Chemotherapy And Autologous Peripheral Blood Stem Cell Rescue For High Risk Acute Leukemia
- 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
Primary Purpose: Treatment
Charles S. Hesdorffer, MD
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
|Herbert Irving Comprehensive Cancer Center at Columbia University||New York, New York 10032|