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

NCT01094405 | Completed Phase 2

• 1 other identifier: VAC003
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Cancer; Epstein-Barr Virus Infections

Keywords

NPC with persistent, recurrent or metastatic disease patients

Outcome Measures

Primary Outcomes (1)

• Clinical Benefit Rate

  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.

  2 Years

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  2 Years

• Duration of Response (DR)

  2 Years

• Progression-free survival (PFS)

  3 Years

• Overall survival (OS)

  3 Years

Study Arms (1)

EBV Vaccine

EXPERIMENTAL

Biological: Recombinant Epstein-Barr Virus (EBV) Vaccine

Interventions

Recombinant Epstein-Barr Virus (EBV) Vaccine BIOLOGICAL

EBV Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Nasopharyngeal Neoplasms; Epstein-Barr Virus Infections; Recurrence

Interventions

Vaccines

Condition Hierarchy (Ancestors)

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; Virus Diseases; Infections; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Anthony TC Chan, MD, FRCP

  Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Anthony TC Chan

Study Record Dates

• First Submitted: March 26, 2010
• First Posted: March 29, 2010
• Study Start: March 31, 2010
• Primary Completion: August 27, 2020
• Study Completion: August 27, 2020
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

HK (1)