Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT01094405
Status:
COMPLETED
Last Update Posted:
2021-07-28
First Post:
2010-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014612', 'term': 'Vaccines'}], 'ancestors': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-26', 'studyFirstSubmitDate': '2010-03-26', 'studyFirstSubmitQcDate': '2010-03-26', 'lastUpdatePostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Benefit Rate', 'timeFrame': '2 Years', '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.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': '2 Years', '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.'}, {'measure': 'Duration of Response (DR)', 'timeFrame': '2 Years', '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.'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': '3 Years', '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.'}, {'measure': 'Overall survival (OS)', 'timeFrame': '3 Years', 'description': 'Overall survival (OS) is defined as the time from start of study treatment to date of death due to any cause.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NPC with persistent, recurrent or metastatic disease patients'], 'conditions': ['Nasopharyngeal Cancer', 'Epstein-Barr Virus Infections']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed diagnosis of nasopharyngeal carcinoma (NPC) (either at initial diagnosis or at recurrence).\n* NPC associated with EBV infection, determined as:\n\n * 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\n * 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\n * NPC with persistent or recurrent disease occurs in the context of an elevated circulating EBV genome level\n* Patients with persistent, recurrent or metastatic NPC that have residual EBV DNA following completion of conventional therapy (chemotherapy or radiotherapy).\n\n * Patients with residual masses at the site(s) of previous disease that are not progressing and for whom no standard therapy is currently appropriate.\n * 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.\n* Disease must be not amenable to potentially curative radiotherapy or surgery.\n* Completion of standard therapy for malignancy at least 4 weeks before trial entry.\n* Written informed consent and the ability of the patient to co-operate with treatment and follow up must be ensured and documented.\n* Age greater than 18 years.\n* World Health Organisation (WHO) performance status of 0 or 1\n* Life expectancy of at least 4 months.\n* 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.\n* Male patients must agree to use appropriate medically approved contraception during the study up to six months after the last vaccination.\n\nExclusion Criteria:\n\n* Chemotherapy, radiotherapy, or major surgery received within 4 weeks of trial entry.\n* Known chronic active infection with Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).\n* Current active autoimmune disease.\n* Current active skin diseases requiring therapy (psoriasis, eczema etc).\n* Ongoing active infection.\n* History of anaphylaxis or severe allergy to vaccination.\n* Allergy to eggs or egg products.\n* Previous myeloablative therapy followed by an autologous or allogeneic haematopoietic stem cell transplant.\n* Patients who have had a splenectomy or splenic irradiation, or with known splenic dysfunction.\n* Receiving current immunosuppressive medication, including corticosteroids (inhaled steroids are acceptable).\n* Pregnant and lactating women.\n* 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.\n* Patients with any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial."}, 'identificationModule': {'nctId': 'NCT01094405', 'briefTitle': 'Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy', 'orgStudyIdInfo': {'id': 'VAC003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EBV Vaccine', 'interventionNames': ['Biological: Recombinant Epstein-Barr Virus (EBV) Vaccine']}], 'interventions': [{'name': 'Recombinant Epstein-Barr Virus (EBV) Vaccine', 'type': 'BIOLOGICAL', 'armGroupLabels': ['EBV Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Department of Clinical Oncology, Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Anthony TC Chan, MD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Anthony TC Chan', 'investigatorFullName': 'CCTU', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}