Modified Vaccinia Ankara (MVA) Vaccine Study

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Vaccines

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