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Sponsored by: |
Fox Chase Cancer Center CCOP Research Base |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002522 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients with relapsed or refractory Hodgkin's lymphoma.
Condition | Intervention | 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: radiation therapy Procedure: syngeneic bone marrow transplantation |
Phase II |
MedlinePlus related topics: | Bone Marrow Transplantation Cancer Hodgkin's Disease Lymphoma |
ChemIDplus related topics: | Cyclophosphamide Etoposide Cisplatin Etoposide phosphate |
Study Type: | Interventional |
Study Design: | Treatment |
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 HODGKIN'S DISEASE |
Study Start Date: | February 1993 |
OBJECTIVES:
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 or 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.
Ages Eligible for Study: | 15 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have refractory or relapsed disease, defined by 1 of the following:
Disease in second or greater remission
No chemoresistant disease, defined as active progression with tumor growth greater than 25% by volume during first-line chemotherapy
Stable residual masses after conventional-dose chemotherapy not considered treatment failures
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Must meet 1 of the following criteria:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Pennsylvania | |||||
Fox Chase - Temple Cancer Center | |||||
Philadelphia, Pennsylvania, United States, 19111-2442 |
Fox Chase Cancer Center CCOP Research Base |
Study Chair: | Kenneth F. Mangan, MD, FACP | Fox Chase Cancer Center CCOP Research Base |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000078283, TUHSC-2162, NCI-V93-0249 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002522 |
Health Authority: | United States: Federal Government |
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