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

NCT01800071 | Completed Phase 1

• 1 other identifier: CRUKD/13/001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 5

Brief Summary

This clinical study is looking at a vaccine called MVA-EBNA1/LMP2. This is a new vaccine that has already been studied in small number of cancer patients. The vaccine is designed to boost a patient's immunity against a common virus. The virus is called Epstein Barr virus or EBV. EBV is sometimes found inside cancer cells and is commonly found in nasopharyngeal cancer cells.

Conditions

Nasopharyngeal Cancer; Epstein Barr Virus Infections

Keywords

Nasopharyngeal cancer; Epstein Barr Virus Infections; Vaccination

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 vaccine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• Patients who have received primary treatment for their malignancy (radiotherapy ± chemotherapy) and up to one additional second-line course of therapy.
• Life expectancy of at least 6 months.
• World Health Organisation (WHO) performance status of 0 or 1 (Appendix 1).
• Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week (Day -7 to Day 1) before the patient receives their first vaccination with MVA-EBNA1/LMP2.
• Laboratory Test Value required Haemoglobin (Hb) ≥10.0 g/dL, Lymphocyte count ≥0.5 x 10\^9/L after ≥ 6 weeks have elapsed from completion of chemotherapy, Absolute neutrophil count (ANC) ≥1.0 x 10\^9/L, Platelet count ≥ 75 x 10\^9/L, Serum bilirubin ≤1.5 x upper limit of normal (ULN), Alkaline phosphatase (ALP) AND alanine aminotransferase (ALT) OR aspartate aminotransferase (AST) ≤ 2.5 x ULN, Calculated creatinine clearance ≥50 mL/min (uncorrected value)
• years or over.
• Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up.

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.

Sponsors & Collaborators

• Cancer Research UK: lead

Study Sites (5)

University of Birmingham

Edgbaston, Birmingham, B15 2TT, United Kingdom

Location

Royal Marsden Hospital

Fulham Road, London, SW3 6JJ, United Kingdom

Location

Velindre Cancer Centre

Cardiff, CF14 2TL, United Kingdom

Location

The Beatson West of Scotland Cancer

Glasgow, G12 0YN, United Kingdom

Location

The Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Nasopharyngeal Neoplasms; Epstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

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 1, 2013
• Primary Completion: March 10, 2017
• Study Completion: March 10, 2017
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

GB (5)