Clinical trial NCT01094405: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Cancer
Epstein-Barr Virus Infections
Keywords: NPC with persistent, recurrent or metastatic disease patients
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2010-03-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Clinical Benefit Rate
timeFrame: 2 Years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 2 Years
measure: Duration of Response (DR)
timeFrame: 2 Years
measure: Progression-free survival (PFS)
timeFrame: 3 Years
measure: Overall survival (OS)
timeFrame: 3 Years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology, Prince of Wales Hospital
Study officials:
affiliation: Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
name: Anthony TC Chan, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: