Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy
Primary Purpose
Nasopharyngeal Cancer, Epstein-Barr Virus Infections
Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Recombinant Epstein-Barr Virus (EBV) Vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Cancer focused on measuring NPC with persistent, recurrent or metastatic disease patients
Eligibility 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.
Sites / Locations
- Department of Clinical Oncology, Prince of Wales Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EBV Vaccine
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Objective Response Rate (ORR)
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)
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)
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)
Overall survival (OS) is defined as the time from start of study treatment to date of death due to any cause.
Full Information
NCT ID
NCT01094405
First Posted
March 26, 2010
Last Updated
July 26, 2021
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01094405
Brief Title
Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy
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 Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 31, 2010 (Actual)
Primary Completion Date
August 27, 2020 (Actual)
Study Completion Date
August 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Cancer, Epstein-Barr Virus Infections
Keywords
NPC with persistent, recurrent or metastatic disease patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EBV Vaccine
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Recombinant Epstein-Barr Virus (EBV) Vaccine
Primary Outcome Measure Information:
Title
Clinical Benefit Rate
Description
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.
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
2 Years
Title
Duration of Response (DR)
Description
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.
Time Frame
2 Years
Title
Progression-free survival (PFS)
Description
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.
Time Frame
3 Years
Title
Overall survival (OS)
Description
Overall survival (OS) is defined as the time from start of study treatment to date of death due to any cause.
Time Frame
3 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony TC Chan, MD, FRCP
Organizational Affiliation
Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Oncology, Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy
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