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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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 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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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, Older Adult)
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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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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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