NCT01147991

Vaccine Therapy in Treating Patients With Epstein-Barr Virus-Related Cancer

A Phase I, Dose Escalation Trial of Recombinant Modified Vaccinia Ankara (MVA)-Based Vaccine Encoding Epstein-Barr Virus Target Antigens

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Cancer Research UK · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gastric Cancer
• Head and Neck Cancer
• Lymphoma
• Lymphoproliferative Disorder
• Nonneoplastic Condition

Interventions

Type	Name	Description
BIOLOGICAL	EBNA1 C-terminal/LMP2 chimeric protein-expressing recombinant modified vaccinia Ankara vaccine
OTHER	laboratory biomarker analysis
OTHER	pharmacological study

Timeline

• Start date: 2005-03-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-06-22
• Last updated: 2012-02-28

Locations

3 sites across 1 country: United Kingdom