Nasopharyngeal CancerPhase 2NCT01094405
Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy
A Phase 2 study testing Recombinant Epstein-Barr Virus (EBV) Vaccine in people with Nasopharyngeal Cancer and Epstein-Barr Virus Infections, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Cancer, Epstein-Barr Virus Infections
- What is being tested?
- Recombinant Epstein-Barr Virus (EBV) Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Mar 2010to 27 Aug 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
About this study
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.
- Being tested
- Recombinant Epstein-Barr Virus (EBV) Vaccine
- Keywords
- NPC with persistent, recurrent or metastatic disease patients
- Medical subject headings
- Nasopharyngeal Neoplasms, Epstein-Barr Virus Infections, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Epstein-Barr Virus (EBV) VaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| EBV Vaccine | Experimental | Not described Receives: Biological: Recombinant Epstein-Barr Virus (EBV) Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Years
Secondary outcomes (4)
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.
Measured: 2 Years
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.
Measured: 2 Years
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.
Measured: 3 Years
Overall survival (OS)
Overall survival (OS) is defined as the time from start of study treatment to date of death due to any cause.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study start31 Mar 2010
- Primary completion27 Aug 2020
- Study completion27 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CCTU, Chinese University of Hong Kong
- Investigators
- Anthony TC Chan, MD, FRCP, Principal investigator, Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094405
- Sponsor's protocol ID
- VAC003
- Status last verified
- Jul 2021
- First submitted
- 26 Mar 2010
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy
- ClinicalTrials.gov ID
- NCT01094405
- Acronym / sponsor ID
- VAC003
- Keywords
- NPC with persistent, recurrent or metastatic disease patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 31 Mar 2010 (actual)
- Primary completion
- 27 Aug 2020 (actual)
- Study completion
- 27 Aug 2020 (actual)
- First posted
- 29 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EBV Vaccine | Experimental | Biological: Recombinant Epstein-Barr Virus (EBV) Vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed diagnosis of nasopharyngeal carcinoma (NPC) (either at initial diagnosis or at recurrence).
- NPC associated with EBV infection, determined as:
- Patients with persistent, recurrent or metastatic NPC that have residual EBV DNA following completion of conventional therapy (chemotherapy or radiotherapy).
- Disease must be not amenable to potentially curative radiotherapy or surgery.
- Completion of standard therapy for malignancy at least 4 weeks before trial entry.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Epstein-Barr Virus (EBV) Vaccine | Biological | EBV Vaccine |
Primary outcome
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.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: 2 Years
Duration of Response (DR)
Time frame: 2 Years
Progression-free survival (PFS)
Time frame: 3 Years
Overall survival (OS)
Time frame: 3 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony TC Chan, MD, FRCP principal investigator
Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Epstein-Barr Virus (EBV) Vaccine in people with Nasopharyngeal Cancer and Epstein-Barr Virus Infections, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Benefit Rate (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.