modified vaccinia ankara (mva) vaccine study

Conditions: Nasopharyngeal Neoplasms; Epstein-Barr Virus Infections

Summary: this is a phase i, dose escalation trial of mva-ebna1/lmp2 vaccine across a pre-defined range of doses in patients in remission having had an ebv+ nasopharyngeal carcinoma (npc).


Eligibility criteria:
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

Keywords: histologically confirmed ebv+ npc patients