Leukemia Clinical Trial
Official title:
High-Dose Cytarabine and Idarubicin Induction, High Dose Etoposide and Cyclophosphamide Intensification, Autologous Stem Cell Transplantation and Interleukin-2 Immune Modulation in Previously Untreated De Novo and Secondary Adult Myeloid Leukemia
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 III trial to study the effectiveness of high-dose combination chemotherapy,
peripheral stem cell transplantation, and interleukin-2 in treating patients who have acute
myeloid leukemia.
OBJECTIVES:
- Determine relapse free survival of patients with previously untreated de novo or
secondary acute myeloid leukemia treated with high dose cytarabine and idarubicin
induction, high dose etoposide and cyclophosphamide intensification, filgrastim
(G-CSF), melphalan, radiotherapy, autologous peripheral blood stem cell (PBSC)
transplantation, and interleukin-2.
- Correlate remission rate and relapse free survival with multidrug resistance phenotype
in patients treated with this regimen.
- Determine stem cell content and presence of cells with leukemia specific markers in
PBSC harvested following high dose etoposide and cyclophosphamide intensification.
- Correlate NK cell expansion (an increase in both proportion and absolute number) during
interleukin-2 therapy following autologous PBSC transplantation with disease free
survival.
OUTLINE:
Induction
- Patients receive cytarabine IV over 1 hour every 12 hours for 6 days and idarubicin IV
over 30 minutes following third, fifth, and seventh doses of cytarabine. Beginning 12
hours after the last dose of cytarabine, patients receive filgrastim (G-CSF)
subcutaneously (SQ) each day until blood counts recover.
Intensification
- Patients receive etoposide IV over 34.3 hours followed 1 hour later by cyclophosphamide
IV over 2 hours for 3 days. Beginning 24 hours after the last dose of cyclophosphamide,
patients receive G-CSF SQ each day until blood counts recover.
Peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells. Patients
receive melphalan IV over 1 hour on day -4 followed by total body irradiation on days -3,
-2, and -1. PBSC are reinfused on day 0.
When blood counts recover, patients receive high dose interleukin-2 SQ on days 1-10 followed
by low dose interleukin-2 SQ on days 11-13. Interleukin-2 treatment repeats every 14 days
for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with
immunologic response to 6 courses of interleukin-2 treatment may continue for 6 additional
courses.
PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study over 5 years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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