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
- 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.
Primary Purpose: Treatment
Kenneth G. Lucas, MD
Milton S. Hershey Medical Center
United States: Federal Government
|Penn State Cancer Institute at Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033-0850|