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.
Verified November 2013 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: November 12, 2013
Last verified: November 2013

March 26, 2010
November 12, 2013
March 2010
March 2014   (final data collection date for primary outcome measure)
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.
Clinical Benefit Rate [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
Clinical benefit rate (CBR, percent of patients experiencing CR, PR or 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 on EBV genome levels in the absence of measurable disease.
Complete list of historical versions of study NCT01094405 on ClinicalTrials.gov Archive Site
  • 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.
  • 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, see appendix 3), 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.
Not Provided
Not Provided
 
Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy
Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Nasopharyngeal Cancer
  • Epstein-Barr Virus Infections
Biological: Recombinant Epstein-Barr Virus (EBV) Vaccine
Experimental: EBV Vaccine
Intervention: Biological: Recombinant Epstein-Barr Virus (EBV) Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
37
March 2014
March 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Anthony TC Chan, MD, FRCP 2632 2119 anthonytcchan@cuhk.edu.hk
Contact: Rosalie Ho, RN 2632 1135 rosalie@clo.cuhk.edu.hk
Hong Kong
 
NCT01094405
VAC003
No
CCTU, Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: Anthony TC Chan, MD, FRCP Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
Chinese University of Hong Kong
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP