Nasopharyngeal Cancer Clinical Trial
Official title:
Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy
Verified date | July 2021 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Department of Clinical Oncology, Prince of Wales Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
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 |
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