efficacy of recombinant epstein-barr virus (ebv) vaccine in patients with nasopharyngeal cancer who had residual ebv dna load after conventional therapy

Conditions: Nasopharyngeal Cancer; Epstein-Barr Virus Infections

Summary: the purpose of this study is to evaluate the efficacy (clinical benefit rate) of mva ebna1/lmp2 vaccine in patients with persistent, recurrent or metastatic nasopharyngeal carcinoma, and its impact on disease progression.


Eligibility criteria:
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.

Keywords: npc with persistent, recurrent or metastatic disease patients