Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT00002552|
Recruitment Status : Completed
First Posted : May 24, 2004
Last Update Posted : April 9, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Multiple Myeloma and Plasma Cell Neoplasm||Biological: filgrastim Biological: sargramostim Drug: carmustine Drug: cyclophosphamide Drug: cytarabine Drug: etoposide Drug: leucovorin calcium Drug: methotrexate Drug: perfosfamide Drug: therapeutic hydrocortisone Procedure: 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 Radiation: radiation therapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Official Title:||AUTOLOGOUS, ALLOGENEIC, OR SYNGENEIC BONE MARROW TRANSPLANTATION IN HODGKIN'S DISEASE, NON-HODGKIN'S LYMPHOMA, AND MULTIPLE MYELOMA|
|Study Start Date :||October 1993|
|Actual Primary Completion Date :||September 2001|
|Actual Study Completion Date :||October 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002552
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|Study Chair:||Roger Dansey, MD||Barbara Ann Karmanos Cancer Institute|