The purpose of this study is to find the largest safe dose of transforming growth factor-beta (TGFb) resistant latent membrane protein (LMP)-specific cytotoxic T cells, to learn what the side effects are and to see whether this therapy might help patients with Hodgkin disease, non-Hodgkin lymphoma and lymphoepithelioma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00368082.
PRIMARY OBJECTIVES:
I. To determine the safety of 2 intravenous injections of autologous or allogeneic TGF-beta-resistant LMP-specific cytotoxic T-lymphocytes (CTL) in patients with relapsed Hodgkin’s or non-Hodgkin’s lymphoma.
II. To determine the survival and the immune function of TGF-beta-resistant LMP specific cytotoxic T-lymphocyte lines.
III. To assess the anti-viral and anti-tumor effects of TGF-beta-resistant LMP-specific CTL.
IV. To obtain preliminary information on the safety and response to an extended dosage regimen.
OUTLINE: This is a dose-escalation study.
Patients receive 2 doses of autologous or allogeneic TGF-beta-resistant LMP-specific cytotoxic T-lymphocytes intravenously (IV) over 1-10 minutes administered 14 days apart. Patients achieving stable disease or partial response at 6 weeks may receive up to 6 additional doses every 1-2 months until achievement of complete response in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up at 1, 2, 4, and 6 weeks, every 3 months for 1 year, at 1.5 years, every 6 months for 4 years, and then yearly for a total of 15 years.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorHelen Elisabeth Heslop
