Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy

Inclusion Criteria

• •Histologically confirmed diagnosis of nasopharyngeal carcinoma (NPC) (either at initial diagnosis or at recurrence).
• •NPC associated with EBV infection, determined as:
• •* NPC occurred in association with a raised serum titre of IgA to EBV viral capsid antigen (VCA) in a patient living in an area of high incidence of EBV+ undifferentiated NPC, or
• •* The presence of EBV has been confirmed in the tumour by immunohistochemistry for EBV antigens or in situ hybridization for EBV early RNA (EBER), or
• •* NPC with persistent or recurrent disease occurs in the context of an elevated circulating EBV genome level
• •Patients with persistent, recurrent or metastatic NPC that have residual EBV DNA following completion of conventional therapy (chemotherapy or radiotherapy).
• •* Patients with residual masses at the site(s) of previous disease that are not progressing and for whom no standard therapy is currently appropriate.
• •* Patients with residual or recurrent disease that is low volume, that is causing minimal or no symptoms and for whom no standard therapy is currently appropriate.
• •Disease must be not amenable to potentially curative radiotherapy or surgery.
• •Completion of standard therapy for malignancy at least 4 weeks before trial entry.
• •Written informed consent and the ability of the patient to co-operate with treatment and follow up must be ensured and documented.
• •Age greater than 18 years.
• •World Health Organisation (WHO) performance status of 0 or 1
• •Life expectancy of at least 4 months.
• •Female patients of child-bearing potential are eligible, provided they have a negative pregnancy test prior to enrolment and agree to use appropriate medically approved contraception during the study up to six months after the last vaccination.
• •Male patients must agree to use appropriate medically approved contraception during the study up to six months after the last vaccination.