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Safety Study of Recombinant Listeria Monocytogenes(Lm)Based Vaccine Virus Vaccine to Treat Oropharyngeal Cancer (REALISTIC:)

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ClinicalTrials.gov Identifier: NCT01598792
Recruitment Status : Terminated (Patient 2 suffered DLT post-vaccination. The vaccine manufacturers withdrew support for the study on commercial grounds.)
First Posted : May 15, 2012
Last Update Posted : May 18, 2016
Liverpool University Hospitals NHS Foundation Trust
Cancer Research UK
Advaxis, Inc.
Recipharm AB
Information provided by (Responsible Party):
Prof. Terry Jones, University of Liverpool

Brief Summary:
It is the investigators intention to investigate whether a specially designed vaccine, based on a genetically modified strain of the bacterium Listeria monocytogenes and called ADXS11-001 is safe to use and is able to boost the immune system of patients presenting with Human Papilloma Virus (HPV) associated oropharyngeal cancer (OPSCC). It is hoped that the vaccine will boost the immune system so that immune cells with cell killing properties are able to attack any cancer cells remaining after the patients have been treated. However, the vaccine is so novel the investigators are not sure whether it is able to do this and before they can answer that question in a larger group of patients they need to make sure that the vaccine is safe to use and has some effect on the immune system in the patients for whom they intend its ultimate use. In a previous study, patients with incurable cervix cancer which is caused by the same virus, were vaccinated with ADXS11-001. Although all patients vaccinated experienced flu-like symptoms, patients tolerated the vaccine well with no patient suffering long term adverse effects of vaccination. However, because the patients and cancer type was so different in this earlier study, the investigators need to test whether ADXS11-001 is also safe in patients with HPV associated OPSCC. That said, the earlier study guided the dosing schedule for the current study and patients entering the REALISTIC trial will receive lower doses than those administered to patients in the earlier cervix cancer study. It is hoped that by doing this, patients will experience fewer side effects of vaccination without reducing the chances of stimulating the immune system.

Condition or disease Intervention/treatment Phase
HPV-16 +ve Oropharyngeal Carcinoma Biological: ADXS11-001 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: REALISTIC: A Phase I, Dose Escalation Trial Of Recombinant Listeria Monocytogenes (Lm)-Based Vaccine Encoding Human Papilloma Virus Genotype 16 Target Antigens (ADXS11-001) In Patients With HPV-16 +ve Oropharyngeal Carcinoma
Study Start Date : February 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Intervention Details:
  • Biological: ADXS11-001
    Escalating doses will be administered: 3.3 x 10e8,1 x 10e9 and 3.3 x 10e9 cfu to patient in 3 different groups. Dose-escalation will only occur if fewer than two patients in each group of six experience Dose Limiting Toxicity (DLT).

Primary Outcome Measures :
  1. Safety [ Time Frame: 12 months ]
    Occurrence of drug-related grade 3 or 4 systemic or local adverse events (defined using the NCI Common Criteria Adverse Events (CTCAE) Version 4.03

Secondary Outcome Measures :
  1. Translational [ Time Frame: 24 Months ]
    Demonstration by ELISPOT assay of the frequency of IFN-γ secreting lymphocytes recognising MHC class I and II-restricted epitopes within HPV-16 E& protein in peripheral blood at sequential time-points before, during and up to ten months after vaccination course. This protocol has been used by our group to demonstrate vaccine induced T cell responses in a previous HPV vaccine trial.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed HPV-16 +ve, p16 +ve OPSCC.
  • Patients in remission from disease, i.e. complete response (CR) or unconfirmed complete response (CRu) in the case of non-surgical treatment or complete macroscopic resection of tumour and associated cervical lymph nodes in patients undergoing surgery.
  • Completion of standard therapy for malignancy at least 6 weeks before trial entry.
  • A positive result following anergy testing.
  • 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 12 months.
  • Haematological and biochemical indices (these measurements must be performed within 8 days prior to the patient going on study):
  • Haematological:

Haemoglobin (Hb) > 10.0 g/dl Neutrophils ≥ 1.5 x 10e9/L Platelets (Plts) ≥ 100 x 10e9/L

  • Baseline liver function tests:

Serum bilirubin ≤ 1.5 x upper normal limit Serum alkaline phosphatase, alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST) < 1.5 x ULN.

  • Baseline renal function test:

Calculated creatinine clearance > 50ml/min (uncorrected value) or isotope clearance measurement > 50ml/min.

  • Female patients of child-bearing potential are eligible, provided they have a negative serum 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:

  • Receiving, or having received, chemotherapy or radiotherapy within 6 weeks of trial entry.
  • Having undergone surgery +/- PORT within 6 weeks of trial therapy
  • A negative result following anergy testing.
  • 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.
  • 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 within 4 weeks of the first dose.
  • Pregnant and lactating women.
  • Ongoing toxic manifestations of previous treatment.
  • Major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not yet recovered.
  • Patients with any other condition which in the Investigator"s opinion would not make the patient a good candidate for the clinical trial.
  • Concurrent congestive heart failure or prior history of class III/ IV cardiac disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598792

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United Kingdom
Velindre NHS Trust
Cardiff, United Kingdom, CF14 2TL
The Royal Liverpool and Broadgreen University Hospitals NHS Foundation Trust
Liverpool, United Kingdom, L7 8XP
Aintree University NHS Foundation Trust
Liverpool, United Kingdom, L9 7AL
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
University of Liverpool
Liverpool University Hospitals NHS Foundation Trust
Cancer Research UK
Advaxis, Inc.
Recipharm AB
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Principal Investigator: Terence Jones, BSc,FRCS,MD University of Liverpool
Additional Information:
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Responsible Party: Prof. Terry Jones, Professor of Head and Neck Surgery, University of Liverpool
ClinicalTrials.gov Identifier: NCT01598792    
Other Study ID Numbers: ISRCTN47069182
2010-019916-20 ( EudraCT Number )
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases