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A Phase I, Dose Escalation Trial of Recombinant Modified Vaccinia Ankara (MVA)-Based Vaccine Encoding Epstein-Barr Virus Target Antigens


Phase 1
18 Years
N/A
Not Enrolling
Both
Nasopharyngeal Neoplasms, Epstein-Barr Virus Infections

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Trial Information

A Phase I, Dose Escalation Trial of Recombinant Modified Vaccinia Ankara (MVA)-Based Vaccine Encoding Epstein-Barr Virus Target Antigens


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine safety and to characterise the toxicity profile of MVA-EBNA1/LMP2 vaccine

Outcome Time Frame:

4 years

Safety Issue:

Yes

Principal Investigator

Anthony TC Chan, MD, FRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Clinical Oncology, The Chinese University of Hong Kong

Authority:

Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Study ID:

VAC002

NCT ID:

NCT01256853

Start Date:

September 2006

Completion Date:

September 2010

Related Keywords:

  • Nasopharyngeal Neoplasms
  • Epstein-Barr Virus Infections
  • histologically confirmed EBV+ NPC patients
  • Neoplasms
  • Nasopharyngeal Neoplasms
  • Vaccinia
  • Virus Diseases
  • Epstein-Barr Virus Infections

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