Status:
COMPLETED
Modified Vaccinia Ankara (MVA) Vaccine Study
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Nasopharyngeal Neoplasms
Epstein-Barr Virus Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01256853
Start Date
September 1 2006
End Date
September 1 2010
Last Update
December 22 2011
Active Locations (1)
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1
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong