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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Nasopharyngeal Cancer; Epstein-Barr Virus Infections	Biological: Recombinant Epstein-Barr Virus (EBV) Vaccine	Phase 2

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	25 participants
Intervention Model:	Single Group Assignment
Masking:	None (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
Study Start Date :	March 2010
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: EBV Vaccine	Biological: Recombinant Epstein-Barr Virus (EBV) Vaccine

Outcome Measures

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Primary Outcome Measures :

1. Clinical Benefit Rate [ Time Frame: 2 Years ]
   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 :

1. Objective Response Rate (ORR) [ Time Frame: 2 Years ]
   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.
2. Duration of Response (DR) [ Time Frame: 2 Years ]
   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.
3. Progression-free survival (PFS) [ Time Frame: 3 Years ]
   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.
4. Overall survival (OS) [ Time Frame: 3 Years ]
   Overall survival (OS) is defined as the time from start of study treatment to date of death due to any cause.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	CCTU, Prof. Anthony TC Chan, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT01094405 History of Changes
Other Study ID Numbers:	VAC003
First Posted:	March 29, 2010
Last Update Posted:	January 12, 2018
Last Verified:	January 2018

Keywords provided by CCTU, Chinese University of Hong Kong:

NPC with persistent, recurrent or metastatic disease patients

Additional relevant MeSH terms:

Virus Diseases; Nasopharyngeal Neoplasms; Epstein-Barr Virus Infections; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases	Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Herpesviridae Infections; DNA Virus Infections; Tumor Virus Infections; Vaccines; Immunologic Factors; Physiological Effects of Drugs