High-Dose Chemotherapy and Radiation Therapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia in Remission
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.
PURPOSE: Phase II trial to study the effectiveness of high-dose radiation therapy and etoposide followed by peripheral stem cell transplantation in treating patients with acute leukemia.
Bone Marrow Ablation
Procedure: peripheral blood stem cell transplantation
Radiation: low-LET electron therapy
Radiation: low-LET photon therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||PHASE II STUDY EVALUATING AUTOLOGOUS PERIPHERAL BLOOD PROGENITOR CELL TRANSPLANTATION FOR ACUTE LEUKEMIAS|
|Study Start Date:||March 1994|
|Study Completion Date:||November 2000|
|Primary Completion Date:||November 2000 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Evaluate the efficacy of myeloablative total-body irradiation and etoposide followed by autologous peripheral blood stem cell (PBSC) transplantation in prolonging the disease-free survival of patients with acute leukemia. II. Investigate the ability of growth factor-primed PBSC to provide hematopoietic reconstitution following myeloablative therapy.
OUTLINE: Patients are treated on Regimen A, then Regimen B. Regimen A: Stem Cell Mobilization. Granulocyte Colony Stimulating Factor (Amgen), G-CSF, NSC-614629. Regimen B: Radiotherapy and Myeloablative Chemotherapy with Hematopoietic Rescue. Total-Body Irradiation, TBI (high-energy electrons used for lung boost); and Etoposide, VP-16, NSC-141540; with Peripheral Blood Stem Cells, PBSC; G-CSF.
PROJECTED ACCRUAL: Up to 45 patients will be studied over approximately 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002567
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Peter Maslak, MD||Memorial Sloan Kettering Cancer Center|