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Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01094405
First received: March 26, 2010
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Nasopharyngeal Cancer
Epstein-Barr Virus Infections
Biological: Recombinant Epstein-Barr Virus (EBV) Vaccine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Clinical Benefit Rate [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
    Clinical benefit rate (CBR, percent of patients experiencing complete response [CR], partial response [PR] or stable disease [SD] for at least 12 weeks from post cycle 2 to cycle 6 measurements) determined according to the Response Evaluation Criteria in Solid Tumours (RECIST), or by immune-related Response criteria (irRC) in the absence of measurable disease.


Secondary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
    ORR is defined as the proportion of patients with confirmed complete response (CR) or confirmed partial response (PR) from post cycle 2 to cycle 6 measurements according to the Response Evaluation Criteria in Solid Tumours (RECIST), relative to the total evaluable patient population.

  • Duration of Response (DR) [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
    DR is defined as the time from the first documentation of objective tumour response to the first documentation of objective tumour progression or to death due to any cause.

  • Progression-free survival (PFS) [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
    PFS is defined as the time from post cycle 2 measurement to first documentation of objective tumour progression, or to death due to any cause.

  • Overall survival (OS) [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
    Overall survival (OS) is defined as the time from start of study treatment to date of death due to any cause.


Estimated Enrollment: 37
Study Start Date: March 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EBV Vaccine Biological: Recombinant Epstein-Barr Virus (EBV) Vaccine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01094405

Contacts
Contact: Anthony TC Chan, MD, FRCP 2632 2119 anthonytcchan@cuhk.edu.hk
Contact: Rosalie Ho, RN 2632 1135 rosalie@clo.cuhk.edu.hk

Locations
Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Anthony TC Chan, MD, FRCP    2632 2119    anthonytcchan@cuhk.edu.hk   
Contact: Rosalie Ho, RN    2632 1135    rosalie@clo.cuhk.edu.hk   
Sub-Investigator: Edwin P Hui, FRCP         
Sub-Investigator: Brigette BY Ma, MD, FRCP         
Sub-Investigator: Stephen L Chan, FRCP         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Anthony TC Chan, MD, FRCP Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: CCTU, Prof. Anthony TC Chan, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01094405     History of Changes
Other Study ID Numbers: VAC003
Study First Received: March 26, 2010
Last Updated: May 21, 2014
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
NPC with persistent, recurrent or metastatic disease patients

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Epstein-Barr Virus Infections
Virus Diseases
DNA Virus Infections
Head and Neck Neoplasms
Herpesviridae Infections
Nasopharyngeal Diseases
Neoplasms
Neoplasms by Site
Neoplasms, Experimental
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on November 19, 2014