Chemotherapy Plus Bone Marrow Transplantation and Filgrastim in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
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.
|Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases||Biological: filgrastim Drug: busulfan Drug: etoposide Procedure: autologous bone marrow transplantation||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Autologous Bone Marrow Transplantation for Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome - A Phase II Pilot Study|
|Study Start Date:||October 1999|
|Study Completion Date:||August 2004|
|Primary Completion Date:||August 2004 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004899
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611|
|Study Chair:||Martin S. Tallman, MD||Robert H. Lurie Cancer Center|