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

Phase 1

Completed

• Conditions: Gastric Cancer; Head and Neck Cancer; Lymphoma; Lymphoproliferative Disorder; Nonneoplastic Condition

• Registration Number: NCT01147991
• Lead Sponsor: Cancer Research UK

Brief 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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2010-06-18
• Study First Submitted QC: 2010-06-18
• Study First Posted: 2010-06-22
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-27
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 ...

Secondary Outcome Measures

Name	Time	Method
Measurement of EBV-genome levels in plasma

Trial Locations

Locations (3)

Royal Marsden - London; 🇬🇧 London, England, United Kingdom

University of Birmingham; 🇬🇧 Birmingham, England, United Kingdom

Christie Hospital; 🇬🇧 Manchester, England, United Kingdom