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AUTOLOGOUS, ALLOGENEIC, OR SYNGENEIC BONE MARROW TRANSPLANTATION IN HODGKIN'S DISEASE, NON-HODGKIN'S LYMPHOMA, AND MULTIPLE MYELOMA
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bone marrow transplantation with chemotherapy may allow doctors to give higher doses of chemotherapy and kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving a bone marrow transplant together with chemotherapy and to see how well it works in treating patients with refractory non-Hodgkin's lymphoma, Hodgkin's lymphoma, or multiple myeloma.
OBJECTIVES: I. Assess the toxicities, response rate, and duration of response associated with high-dose cyclophosphamide, etoposide, carmustine or high-dose cyclophosphamide and total-body irradiation followed by autologous, allogeneic, or syngeneic bone marrow transplant in patients with refractory or high-risk non-Hodgkin's lymphoma, Hodgkin's disease, or multiple myeloma. II. Evaluate any prognostic factors. OUTLINE: Patients with prior radiotherapy (greater than 2,000 cGy) receive cyclophosphamide IV over 2 hours and etoposide IV over at least 30 minutes on days -7 through -4 followed by carmustine IV over 2 hours on day -3. Patients receive allogeneic or autologous bone marrow transplantation on day 0. Patients with or without prior radiotherapy (less than 2,000 cGy) receive cyclophosphamide IV over 2 hours on days -8 through -5 followed by total body irradiation on days -4 through -1. Patients receive allogeneic or autologous bone marrow transplantation on day 0. Prior to autologous bone marrow transplantation and following myeloablative chemotherapy, patients undergo mobilization consisting of cytarabine subcutaneously every 12 hours for 6 doses. Approximately 24 hours later, patients receive sargramostim (GM-CSF) subcutaneously. Peripheral blood stem cells are collected every 1-3 days beginning when blood counts recover and continuing until sufficient number of cells are reached. PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.
Age
0 - 70 years
Sex
ALL
Healthy Volunteers
No
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Start Date
October 1, 1993
Primary Completion Date
September 1, 2001
Completion Date
October 1, 2003
Last Updated
April 9, 2013
40
ESTIMATED participants
filgrastim
BIOLOGICAL
sargramostim
BIOLOGICAL
carmustine
DRUG
cyclophosphamide
DRUG
cytarabine
DRUG
etoposide
DRUG
leucovorin calcium
DRUG
methotrexate
DRUG
perfosfamide
DRUG
therapeutic hydrocortisone
DRUG
allogeneic bone marrow transplantation
PROCEDURE
autologous bone marrow transplantation
PROCEDURE
in vitro-treated bone marrow transplantation
PROCEDURE
peripheral blood stem cell transplantation
PROCEDURE
syngeneic bone marrow transplantation
PROCEDURE
radiation therapy
RADIATION
Lead Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
NCT06263491
NCT06337318
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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