Peripheral Stem Transplantation in Treating Patients With Refractory or Relapsed Lymphoma - Article CABG
Clinical Trial: Peripheral Stem Transplantation in Treating Patients With Refractory or Relapsed Lymphoma
This study is currently recruiting patients.
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous and allogeneic peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs to kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects of autologous peripheral stem cell transplantation followed by allogeneic peripheral stem cell transplantation and to see how well they work in treating patients with refractory or relapsed lymphoma.
|Condition||Treatment or Intervention||Phase|
|childhood Hodgkin's lymphoma |
childhood non-Hodgkin's lymphoma
Graft Versus Host Disease
| Drug: autologous lymphocytes |
Drug: mycophenolate mofetil
Procedure: biological response modifier therapy
Procedure: bone marrow ablation with stem cell support
Procedure: graft versus host disease prophylaxis/therapy
Procedure: graft versus tumor induction
Procedure: leukocyte therapy
Procedure: peripheral blood lymphocyte therapy
Procedure: peripheral blood stem cell transplantation
Procedure: radiation therapy
Procedure: supportive care/therapy
|Phase I |
MedlinePlus related topics: Hodgkin's Disease; Immune System and Disorders; Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I/II Study of Autologous Peripheral Blood Stem Cell (PBSC) Transplantation Followed by Nonmyeloablative Allogeneic PBSC Transplantation in Patients With Refractory or Relapsed Lymphoma
- Assess engraftment of HLA-identical peripheral blood stem cell (PBSC) allografts given after conditioning with total body irradiation and postgrafting immunosuppression with cyclosporine and mycophenolate mofetil in patients with refractory or relapsed lymphoma treated with initial autologous PBSC transplantation.
- Determine nonrelapse mortality at day 100 in patients treated with this regimen.
- Determine disease-free and overall survival of patients treated with this regimen.
Patients who do not have autologous peripheral blood stem cells (PBSC) stored receive mobilization on another protocol, then have PBSC collected and stored. Patients then proceed to conditioning and transplantation.
Patients may receive one of two conditioning regimens.
- Regimen 1: Patients receive cyclophosphamide IV on days -6 and -5 followed by total body irradiation (TBI) twice a day on days -3 to -1. Autologous PBSC are reinfused on day 0.
- Regimen 2: Patients receive carmustine IV over 3 hours on day -7, etoposide IV over 2 hours and cytarabine IV over 3 hours twice a day on days -6 to -3, and melphalan IV over 30 minutes on day -2. Autologous PBSC are reinfused on day 0. Some patients may receive involved field irradiation to bulky disease after autologous PBSC reinfusion and before nonmyeloablative allograft.
Within 40-120 days after autologous PBSC transplantation, patients proceed to nonmyeloablative allograft. Cyclosporine administered orally twice daily on days -3 to 56, then tapered based on disease risk. TBI is administered on day 0 followed by allogeneic PBSC infusion. Patients also receive oral mycophenolate mofetil twice a day beginning on day 0 and continuing until day 27.
Based on day 56 disease status, patients may receive donor lymphocyte infusion (DLI) if there is evidence of disease progression and no evidence of graft-vs-host disease. DLI may be repeated every 65 days for up to 4 doses.
Patients are followed weekly for 3 months, at 4 and 6 months, every 6 months for 2 years, and then annually until 5 years after transplantation.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.
Ages Eligible for Study: up to 65 Years, Genders Eligible for Study: Both
- Primary Hodgkin's or non-Hodgkin's lymphoma
- Refractory or relapsed disease after standard chemotherapy
- At high-risk of relapse with conventional autografting
- Tumor detectable by radiograph or bone marrow biopsy
- HLA genotypically- or phynotypically-identical related donor available
- Not identical twin
- Age 12 and over
- Able to donate peripheral blood stem cells (PBSC) and lymphocytes
PATIENT CHARACTERISTICS: Age:
- 65 and under
- Karnofsky 60-100%
- At least 3 months
- No life expectancy severely limited by disease other than lymphoma
- Not specified
- Not at high risk for veno-occlusive disease of the liver
- Bilirubin no greater than 2.0 mg/dL
- SGOT or SGPT no greater than 2 times normal
- Creatinine no greater than 2.0 mg/dL
- Creatinine clearance at least 50 mL/min
- Cardiac ejection fraction at least 45% by MUGA or cardiac echo (for patients with a history of cardiac disease or anthracycline use)
- No poorly controlled hypertension
- DLCO at least 50% of predicted
- HIV negative
- Not pregnant
- Fertile patients must use effective contraception during and for 1 year after study participation
PRIOR CONCURRENT THERAPY: Biologic therapy:
- No prior autologous PBSC transplantation
- No concurrent growth factors during mycophenolate mofetil administration
- See Disease Characteristics
- Not specified
- At least 3 months since prior radiotherapy to the mediastinum
- Not specified
Location and Contact Information
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, 84112, United States; Recruiting
Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109-1024, United States; Recruiting
Universitaet Leipzig, Leipzig, D-04103, Germany; Recruiting
David G. Maloney, MD, PhD, Study Chair, Fred Hutchinson Cancer Research Center
Record last reviewed: June 2004
Last Updated: February 7, 2005
Record first received: June 2, 2000
ClinicalTrials.gov Identifier: NCT00005803
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005