Combination Chemotherapy and Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00002521|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 1, 2010
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow and peripheral stem cell transplantation may allow doctors to give high doses of chemotherapy and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with cyclophosphamide, etoposide and cisplatin followed by bone marrow and/or peripheral stem cell transplantation in patients with relapsed or refractory intermediate- or high-grade non-Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation Procedure: syngeneic bone marrow transplantation Radiation: radiation therapy||Phase 2|
- Determine the curative potential of high-dose cyclophosphamide, etoposide, and cisplatin (CEP) with syngeneic or autologous bone marrow and/or autologous peripheral blood stem cell rescue in patients with relapsed or refractory, stage I-IV, intermediate- or high-grade non-Hodgkin's lymphoma.
- Determine the overall response rate and survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the differences in the rates of engraftment, response, and survival of patients treated with bone marrow vs peripheral blood stem cell transplantation.
- Determine the response rate and survival of patients treated with consolidative radiotherapy after recovery from transplantation.
- Determine the toxic effects of consolidative radiotherapy after recovery from transplantation in these patients.
OUTLINE: Syngeneic or autologous bone marrow and/or autologous peripheral blood stem cells (PBSC) are harvested. Syngeneic bone marrow transplantation is preferred for patients with a qualifying identical twin donor. Patients without a syngeneic donor who have a history of lymphomatous involvement of the bone marrow and are profoundly hypocellular undergo harvest of PBSC alone. Patients without a syngeneic donor who have no history of lymphomatous involvement of the bone marrow undergo harvest of autologous bone marrow or PBSC.
Patients receive conditioning comprising cyclophosphamide IV over 1 hour on days -6 to -3 and etoposide IV over 1 hour every 12 hours and cisplatin IV continuously on days -6 to -4. Bone marrow and/or PBSC are infused on day 0. (Patients requiring more than 25 bags of stem cells receive bone marrow transplantation on day 0 and PBSC transplantation on day 1.)
After recovery from transplantation, eligible patients receive consolidative radiotherapy to any site of prior bulk disease (greater than 5 cm) present at any time before transplantation and any site of disease present at the time of transplantation.
Patients are followed at 3, 6, and 12 months and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||HIGH-DOSE CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CISPLATIN (CEP) WITH RESCUE BY AUTOLOGOUS BONE MARROW OR AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH RELAPSED OR REFRACTORY NON-HODGKIN'S LYMPHOMA (INTERMEDIATE AND HIGH-GRADE HISTOLOGIES)|
|Study Start Date :||February 1993|
|Primary Completion Date :||February 2000|
|Study Completion Date :||February 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002521
|United States, Pennsylvania|
|Fox Chase - Temple Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111-2442|
|Study Chair:||Kenneth F. Mangan, MD, FACP||Fox Chase Cancer Center|