Modified Vaccinia Ankara (MVA) Vaccine Study

This is an interventional treatment trial for Nasopharyngeal Neoplasms focused on measuring histologically confirmed EBV+ NPC patients Read More

Inclusion Criteria:

• Histologically confirmed NPC, in which the presence of EBV within the malignant cells has been demonstrated by (1) EBER (EBV early RNA) in situ hybridisation in more than 50% of the malignant cells, or (2) undifferentiated or poorly differentiated carcinoma histology in association with a raised serum titer of IgA to EBV VCA.
• Patients in remission from disease, ie complete response (CR) or unconfirmed complete response (CRu).
• Completion of standard therapy for malignancy at least 12 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.

• Haematological and biochemical indices (these measurements must be performed within 28 days prior to the patient going on study):

  • Haemoglobin (Hb) > 10.0 g/dl
  • Lymphocytes > 1.0 x 109/L (or above the lower limit of normal range of institutional laboratory)
  • Neutrophils ≥ 1.5 x 109/L
  • Platelets (Plts) ≥ 100 x 109/L
  • baseline liver function tests :
  • Serum bilirubin ≤ 1.5 x upper normal limit
  • Serum alkaline phosphatase, alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST) < 1.5 x ULN.
  • baseline renal function test:
  • calculated creatinine clearance > 50ml/min 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:

• Receiving current chemotherapy or radiotherapy, or received within 12 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.
• 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 and Cancer Research UK should not exclude the patient.
• Major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not yet recovered.
• Patients with any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
• Concurrent congestive heart failure or prior history of class III/ IV cardiac disease