- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01094405
Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy
July 26, 2021 updated by: CCTU, Chinese University of Hong Kong
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, Hong Kong
- Department of Clinical Oncology, Prince of Wales Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EBV Vaccine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Benefit Rate
Time Frame: 2 Years
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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.
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2 Years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: 2 Years
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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.
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2 Years
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Duration of Response (DR)
Time Frame: 2 Years
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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.
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2 Years
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Progression-free survival (PFS)
Time Frame: 3 Years
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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.
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3 Years
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Overall survival (OS)
Time Frame: 3 Years
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Overall survival (OS) is defined as the time from start of study treatment to date of death due to any cause.
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3 Years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anthony TC Chan, MD, FRCP, Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 31, 2010
Primary Completion (Actual)
August 27, 2020
Study Completion (Actual)
August 27, 2020
Study Registration Dates
First Submitted
March 26, 2010
First Submitted That Met QC Criteria
March 26, 2010
First Posted (Estimate)
March 29, 2010
Study Record Updates
Last Update Posted (Actual)
July 28, 2021
Last Update Submitted That Met QC Criteria
July 26, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- DNA Virus Infections
- Tumor Virus Infections
- Herpesviridae Infections
- Nasopharyngeal Carcinoma
- Nasopharyngeal Neoplasms
- Epstein-Barr Virus Infections
Other Study ID Numbers
- VAC003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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