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

Launched by CHINESE UNIVERSITY OF HONG KONG · Mar 26, 2010

Keywords

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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.