Expired Study
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Chicago, Illinois 60611


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Morphologically proven (from bone marrow aspirate smears or touch preps of marrow biopsy) of myelodysplastic syndrome or acute myelogenous leukemia (AML) of 1 of the following subtypes: - Acute myeloblastic leukemia (FAB M1 or M2) - Acute promyelocytic leukemia (FAB M3) - Acute myelomonocytic leukemia (FAB M4) - Acute monocytic leukemia (FAB M5) - Acute erythroleukemia (FAB M6) - In complete remission at time of marrow or stem cell harvesting - No relapsed AML unless bone marrow or peripheral blood stem cells previously harvested in remission are available for transplantation - May have had secondary AML that is either therapy related or that has evolved from an antecedent myelodysplastic syndrome - History of CNS disease during induction allowed provided inactive and cytologic examination of spinal fluid from preharvest lumbar puncture shows no evidence of leukemia - No occult or symptomatic leukemic meningitis during induction therapy or prior to bone marrow harvesting PATIENT CHARACTERISTICS: Age: - Physiologic 65 and under Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 2.0 mg/dL Renal: - Creatinine no greater than 2.0 mg/dL - Creatinine clearance at least 50 mL/min Cardiovascular: - Cardiac ejection fraction normal Pulmonary: - FEV1 at least 60% predicted - DLCO at least 60% predicted Other: - HIV negative - No evidence of persistent infections - No concurrent organ damage or medical problems that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified Other: - No concurrent antibiotics


NCT ID:

NCT00004899


Primary Contact:

Study Chair
Martin S. Tallman, MD
Robert H. Lurie Cancer Center


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60611
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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