Lymphoma Clinical Trial
Official title:
A Phase I, Dose Escalation Trial of Recombinant Modified Vaccinia Ankara (MVA)-Based Vaccine Encoding Epstein-Barr Virus Target Antigens
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective
immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in
treating patients with Epstein-Barr virus and cancer.
OBJECTIVES:
Primary
- To determine safety and to characterize the toxicity profile of EBNA1 C-terminal/LMP2
chimeric protein-expressing recombinant modified vaccinia Ankara vaccine in patients in
remission having been treated conventionally for Epstein-Barr virus (EBV) and
malignancy.
- To describe changes in the frequency of functional T-cell responses to major
histocompatibility complex (MHC) class I and II-restricted epitopes within EBNA1 and
LMP2 in peripheral blood at sequential time-points before, during, and up to nine
months after the vaccination course in these patients.
Secondary
- To assess changes in levels of EBV genome in plasma in these patients.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive EBNA1 C-terminal/LMP2 chimeric protein-expressing recombinant modified
vaccinia Ankara vaccine intradermally on day 1. Treatment repeats every 3 weeks for 3
courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for immune function, biomarker, and pharmacological
studies.
After completion of study treatment, patients are followed up at weeks 11 and 14, and at 6
months and 1 year.
;
Primary Purpose: Treatment
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