Leukemia Clinical Trial
Official title:
Autologous Bone Marrow Transplantation for Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome - A Phase II Pilot Study
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing and die. Bone marrow transplantation may be able to replace cells that
were destroyed by chemotherapy. Colony-stimulating factors such as filgrastim may increase
the number of immune cells found in bone marrow or peripheral blood and may help a person's
immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus bone marrow
transplantation and filgrastim in treating patients who have acute myelogenous leukemia or
myelodysplastic syndrome.
OBJECTIVES:
- Determine the overall survival and disease free survival of patients with acute
myelogenous leukemia or myelodysplastic syndrome treated with busulfan and etoposide
followed by autologous bone marrow transplantation and filgrastim (G-CSF).
- Assess the toxicities of this regimen in this patient population.
- Assess the hematologic effects and toxicities of G-CSF given in this setting to these
patients.
- Determine whether G-CSF stimulates leukemic relapse in these patients.
- Determine whether G-CSF has an affect on platelet recovery in this setting in these
patients.
OUTLINE: Patients are stratified according to first, second, or third remission. Patients
undergo bone marrow collection.
Patients receive oral busulfan every 6 hours for 16 doses on days -5, -4, -3, and -2.
Patients receive etoposide IV over 4 hours on days -4, -3, and -2. Bone marrow is reinfused
36-48 hours after the last dose of etoposide. Patients receive filgrastim (G-CSF) IV daily
beginning 2-4 hours after bone marrow reinfusion until hematopoietic recovery.
Patients are followed monthly for 1 year, every 3 months for 1 year, and then every 6 months
thereafter.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 2 years.
;
Primary Purpose: Treatment
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