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)
- 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.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Kenneth F. Mangan, MD, FACP
Fox Chase Cancer Center
United States: Federal Government
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