Trials Sponsors Conditions Drugs Pricing

Conditions

Epstein Barr Virus Infections Nasopharyngeal Cancer

Keywords

Nasopharyngeal cancerEpstein Barr Virus InfectionsVaccination

Outcome Measures

Primary Outcomes (2)

Immune response to three cycles of MVA-EBNA1/LMP2 vaccine
To be determined by ex vivo ELIspot assays quantifying EBV EBNA1 and LMP2-specific effectors in samples before vaccination, during the three cycle vaccine course and within 4 weeks after the third vaccine cycle.
pre-vaccination to 4 weeks post third vaccine
Occurrence of adverse events defined according to NCI CTCAE version 4.02
12 months

Secondary Outcomes (3)

Immune memory and recall response to MVA-EBNA1/LMP2 vaccination
pre and post vaccines one and four.
Measurement of EBV genome levels in plasma before, during and after vaccination
pre- vaccination to 12 months post vaccination
Tumour response as determined by Immune-Related Response Criteria (irRC)
6 months

Interventions

MVA-EBNA1/LMP2 vaccineDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically confirmed NPC in which the presence of EBV has been confirmed in the tumour by immunohistochemistry for viral antigens or EBV early RNA (EBER) fluorescent in situ hybridisation (FISH).
Patients in remission or with current disease for whom no standard therapy is currently appropriate or required.

Sponsors & Collaborators

Cancer Research UK
Otherlead

Study Sites (5)

University of Birmingham

Edgbaston, Birmingham, B15 2TT, United Kingdom

Royal Marsden Hospital

Fulham Road, London, SW3 6JJ, United Kingdom

Velindre Cancer Centre

Cardiff, CF14 2TL, United Kingdom

The Beatson West of Scotland Cancer

Glasgow, G12 0YN, United Kingdom

The Christie Hospital

Manchester, M20 4BX, United Kingdom

MeSH Terms

Conditions

Nasopharyngeal NeoplasmsEpstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Enrollment

22 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Purpose: TREATMENT
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 25, 2013

First Posted

February 27, 2013

Study Start

March 2013

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Radiotherapy, chemotherapy, endocrine therapy, immunotherapy or investigational medicinal products within 6 weeks prior to trial entry.
Patients who, in the opinion of the investigator and multidisciplinary team managing the patient, may require another oncological treatment within 14 weeks of the first vaccination.
Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or Grade 1 toxicities, which in the opinion of the Investigator and the Sponsor should not exclude the patient.
Current active auto-immune disease requiring therapy.
Current active eczema requiring therapy.
Allergy to eggs or egg products.
History of anaphylaxis or severe allergy to previous vaccinations or medications. Patients with a documented history of allergy to gentamicin should be discussed with the Sponsor prior to trial entry.
Previous splenectomy or splenic radiation, or with known splenic dysfunction.
Receiving current immunosuppressive medication including systemic use of corticosteroids. Prophylactic use of inhaled steroids is permitted.
Ability to become pregnant (or already pregnant or lactating). However, those female patients who have a negative serum or urine pregnancy test before enrolment and agree to use two highly effective forms of contraception (oral, injected or implanted hormonal contraception and condom, have a intra-uterine device and condom, diaphragm with spermicidal gel and condom) during the trial and for six months afterwards are considered eligible.
Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using one form of highly effective contraception \[condom plus spermicide\] during the trial and for six months afterwards). Men with pregnant or lactating partners should be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure to the foetus or neonate.
Major thoracic or abdominal surgery from which the patient has not yet recovered.
At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
History of Unstable Angina Pectoris or Myocardial Infarction up to 6 Months prior to trial entry.
+2 more criteria

A Phase Ib Trial of MVA-EBNA1/LMP2 Vaccine in Nasopharyngeal Carcinoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations