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.

Exclusion Criteria:

- Chemotherapy, radiotherapy, or major surgery received within 4 weeks of trial entry.

- Known chronic active infection with Hepatitis B, Hepatitis C or Human
Immunodeficiency Virus (HIV).

- Current active autoimmune disease.

- Current active skin diseases requiring therapy (psoriasis, eczema etc).

- Ongoing active infection.

- History of anaphylaxis or severe allergy to vaccination.

- Allergy to eggs or egg products.

- Previous myeloablative therapy followed by an autologous or allogeneic haematopoietic
stem cell transplant.

- Patients who have had a splenectomy or splenic irradiation, or with known splenic
dysfunction.

- Receiving current immunosuppressive medication, including corticosteroids (inhaled
steroids are acceptable).

- Pregnant and lactating women.

- Ongoing toxic manifestations of previous treatment. Exceptions to this are alopecia
or certain Grade 1 toxicities which in the opinion of the Investigator should not
exclude the patient.

- Patients with any other condition which in the Investigator's opinion would not make
the patient a good candidate for the clinical trial.