Allogeneic Epstein Barr Virus-Specific Cytotoxic T-Lymphocytes in Treating Patients With Progressive, Relapsed, or Refractory Hodgkin's Lymphoma
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Donor white blood cells that are treated in the laboratory with Epstein-Barr virus may be effective treatment for Hodgkin's lymphoma.
PURPOSE: Phase I trial to study the effectiveness of allogeneic Epstein-Barr virus-specific cytotoxic T cells in treating patients who have progressive, relapsed, or refractory Hodgkin's lymphoma.
Biological: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
Drug: fludarabine phosphate
Procedure: peripheral blood stem cell transplantation
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Pilot Trial to Evaluate the Toxicity of Epstein-Barr Virus Specific T-Lymphocytes or Peripheral Blood Mononuclear Cells for the Treatment of Relapsed/Refractory Hodgkin's Disease|
|Study Start Date:||April 2000|
- Determine the toxicity of allogeneic Epstein Barr virus (EBV)-specific cytotoxic T-lymphocytes (EBV CTL) in patients with progressive, relapsed, or refractory EBV-positive Hodgkin's lymphoma.
- Detect alterations in the anti-EBV cellular immunity of patients treated with EBV CTL.
OUTLINE: Donors undergo leukapheresis. Epstein Barr virus-specific cytotoxic T lymphocytes (EBV CTL) are cultured in vitro.
Patients receive an infusion of EBV CTL over 10 minutes on day 0. The EBV CTL infusion is preceded by 3 doses of fludarabine. Patients then receive interleukin-2 injections for 12 days after the EBV CTL infusion.
Patients are followed weekly for 1.5 months, twice a month for 1.5 months, and then monthly for 3 months.
PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006100
|United States, Pennsylvania|
|Penn State Cancer Institute at Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033-0850|
|Study Chair:||Kenneth G. Lucas, MD||Milton S. Hershey Medical Center|