High Dose Chemotherapy And Autologous Peripheral Blood Stem Cell Rescue For High Risk Acute Leukemia
N/A
N/A
Both
Leukemia
Trial Information
High Dose Chemotherapy And Autologous Peripheral Blood Stem Cell Rescue For High Risk 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Charles S. Hesdorffer, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Herbert Irving Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000068386
NCT ID:
NCT00008190
Start Date:
March 1999
Completion Date:
May 2008
Related Keywords:
- Leukemia
- recurrent childhood acute lymphoblastic leukemia
- recurrent childhood acute myeloid leukemia
- recurrent adult acute myeloid leukemia
- recurrent adult acute lymphoblastic leukemia
- adult acute myeloid leukemia in remission
- adult acute lymphoblastic leukemia in remission
- childhood acute myeloid leukemia in remission
- childhood acute lymphoblastic leukemia in remission
- secondary acute myeloid leukemia
- Leukemia
Name | Location |
|---|---|
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
