Brief Title
Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy
Official Title
Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy
Brief Summary
The purpose of this study is to evaluate the efficacy (clinical benefit rate) of MVA
EBNA1/LMP2 vaccine in patients with persistent, recurrent or metastatic nasopharyngeal
carcinoma, and its impact on disease progression.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Clinical Benefit Rate
Secondary Outcome
Objective Response Rate (ORR)
Condition
Nasopharyngeal Cancer
Intervention
Recombinant Epstein-Barr Virus (EBV) Vaccine
Study Arms / Comparison Groups
EBV Vaccine
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
25
Start Date
March 31, 2010
Completion Date
December 31, 2021
Primary Completion Date
December 31, 2021
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of nasopharyngeal carcinoma (NPC) (either at
initial diagnosis or at recurrence).
- NPC associated with EBV infection, determined as:
- NPC occurred in association with a raised serum titre of IgA to EBV viral capsid
antigen (VCA) in a patient living in an area of high incidence of EBV+
undifferentiated NPC, or
- The presence of EBV has been confirmed in the tumour by immunohistochemistry for
EBV antigens or in situ hybridization for EBV early RNA (EBER), or
- NPC with persistent or recurrent disease occurs in the context of an elevated
circulating EBV genome level
- Patients with persistent, recurrent or metastatic NPC that have residual EBV DNA
following completion of conventional therapy (chemotherapy or radiotherapy).
- Patients with residual masses at the site(s) of previous disease that are not
progressing and for whom no standard therapy is currently appropriate.
- Patients with residual or recurrent disease that is low volume, that is causing
minimal or no symptoms and for whom no standard therapy is currently appropriate.
- Disease must be not amenable to potentially curative radiotherapy or surgery.
- Completion of standard therapy for malignancy at least 4 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.
- 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:
- Chemotherapy, radiotherapy, or major surgery received within 4 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 (inhaled
steroids are acceptable).
- 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 should not exclude
the patient.
- Patients with any other condition which in the Investigator's opinion would not make
the patient a good candidate for the clinical trial.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Anthony TC Chan, MD, FRCP, ,
Location Countries
Hong Kong
Location Countries
Hong Kong
Administrative Informations
NCT ID
NCT01094405
Organization ID
VAC003
Responsible Party
Principal Investigator
Study Sponsor
Chinese University of Hong Kong
Study Sponsor
Anthony TC Chan, MD, FRCP, Principal Investigator, Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
Verification Date
June 2020