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Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy

NCT01094405•Chinese University of Hong Kong

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+6 more criteria

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).
+3 more criteria

Locations (1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

Key Dates

Start Date

March 31, 2010

Primary Completion Date

August 27, 2020

Completion Date

August 27, 2020

Last Updated

July 28, 2021

Enrollment

ACTUAL participants

Conditions

Nasopharyngeal CancerEpstein-Barr Virus Infections

Interventions

Recombinant Epstein-Barr Virus (EBV) Vaccine

BIOLOGICAL

Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-HodgkinLymphomas

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RECRUITING

Discovery of Biomarkers for Intrinsic Radiation Sensitivity in Cancer Patients

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 28, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy

Inclusion Criteria

Exclusion Criteria

Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-HodgkinLymphomas

Discovery of Biomarkers for Intrinsic Radiation Sensitivity in Cancer Patients

QL1706 (PD-1/CTLA-4 Bi-specific Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma.

Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma

Adebrelimab and Chemoradiotherapy in High-risk LANPC

Cadonilimab (PD-1/CTLA-4 Bispecific Blockade) and Chemoradiotherapy in Nasopharyngeal Carcinoma (GEMSTONE)