Vaccine Therapy in Treating Patients With Epstein-Barr Virus-Related Cancer
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.
Head and Neck Cancer
Biological: EBNA1 C-terminal/LMP2 chimeric protein-expressing recombinant modified vaccinia Ankara vaccine
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I, Dose Escalation Trial of Recombinant Modified Vaccinia Ankara (MVA)-Based Vaccine Encoding Epstein-Barr Virus Target Antigens|
- Occurrence of drug-related grade 3 or 4 systemic or local adverse events (defined using the NCI CTCAE version 3.0)
- Occurrence of local skin reactions considered related to the vaccination
- Occurrence of drug-related systemic reactions (e.g., transient fever)
- Demonstration by ELIspot assays of the frequency of T-lymphocytes recognizing 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 9 mo ...
- Measurement of EBV-genome levels in plasma
|Study Start Date:||March 2005|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01147991
|University of Birmingham|
|Birmingham, England, United Kingdom, B15 2TT|
|Royal Marsden - London|
|London, England, United Kingdom, SW3 6JJ|
|Manchester, England, United Kingdom, M20 4BX|
|Principal Investigator:||Neil M Stevens, MD||University of Birmingham|