Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01094405
Other study ID # VAC003
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 31, 2010
Est. completion date August 27, 2020

Study information

Verified date July 2021
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date August 27, 2020
Est. primary completion date August 27, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Biological:
Recombinant Epstein-Barr Virus (EBV) Vaccine


Locations

Country Name City State
Hong Kong Department of Clinical Oncology, Prince of Wales Hospital Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 2 Years
Secondary 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. 2 Years
Secondary 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. 3 Years
Secondary Overall survival (OS) Overall survival (OS) is defined as the time from start of study treatment to date of death due to any cause. 3 Years
See also
  Status Clinical Trial Phase
Completed NCT00370890 - A Trial of Adjuvant Chemotherapy in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy Phase 3
Recruiting NCT04340024 - Discovery of Biomarkers for Intrinsic Radiation Sensitivity in Cancer Patients
Completed NCT00697619 - To Evaluate the Efficacy of ZOMETA® in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer Phase 2
Completed NCT00078546 - EBV-Specific CTLs Following CD45 Antibody to Patients With Epstein-Barr Virus (EBV) + Nasopharyngeal Carcinoma (NPC) Phase 1
Recruiting NCT04453826 - Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma Phase 3
Active, not recruiting NCT01074021 - Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer Phase 3
Active, not recruiting NCT03890185 - Docetaxal & Cisplatin vs LDFRT + Docetaxal & Cisplatin in Locally Advanced NPC Phase 2
Not yet recruiting NCT04158414 - Applying PET/MR in Oncology - a Prospective Project N/A
Completed NCT02608073 - A Study of Capecitabine (Xeloda) as First-Line Chemotherapy in Participants With Metastatic Nasopharyngeal Cancer Phase 2
Completed NCT03656250 - Assessment of Treatment Response of Nasopharyngeal Cancer Using Simultaneous 18F-FDG-PET and MRI
Recruiting NCT02012699 - Integrated Cancer Repository for Cancer Research
Recruiting NCT04476641 - A Study of DC-CIK Immunotherapy in the Treatment of Solid Tumors Phase 2
Terminated NCT03144661 - An Open-Label Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies Phase 1
Not yet recruiting NCT06414577 - Irinotecan Liposomes in Combination With Nituzumab for the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma After Failure of First-Line or Higher Immunotherapy Phase 2
Recruiting NCT03003182 - A Study of Nasopharyngeal Carcinoma From Guangdong N/A
Not yet recruiting NCT06349889 - Adebrelimab and Chemoradiotherapy in High-risk Locoregionally Advanced Nasopharyngeal Carcinoma Phase 2
Not yet recruiting NCT05305131 - Phase II Randomised Trial of Induction Gemcitabine and Cisplatin Versus Gemcitabine, Cisplatin, Pembrolizumab and Bevacizumab (GPPB) in Nasopharyngeal Cancer Phase 2
Completed NCT01800071 - A Phase Ib Trial of MVA-EBNA1/LMP2 Vaccine in Nasopharyngeal Carcinoma Phase 1
Recruiting NCT00304694 - Whole-Body 18F-FDG PET in Induction Chemotherapeutic Response for Advanced NPC Patients N/A
Recruiting NCT05638269 - A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases in China