Head and neck cancer Cancer Malignant neoplasms of head face and neck
Conditions
Interventions
ADXS11-001 - the patient will recieve 3 vaccinations. The vaccine will be given on Day 1 of each cycle. An interval of at least 28 days should occur between any two vaccinations. To proceed to the nex
Sponsors
University Hospital Aintree (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed HPV-16 +ve, p16 +ve OPSCC 2. 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 3. Completion of standard therapy for malignancy at least 6 weeks before trial entry 4. A positive result following anergy testing 5. Written informed consent and the ability of the patient to co-operate with treatment and follow up must be ensured and documented 6. Age greater than 18 years 7. World Health Organisation (WHO) performance status of 0 or 1 8. Life expectancy of at least 12 months 9. Haematological and biochemical indices (these measurements must be performed within 8 days prior to the patient going on study) 10. Haematological: 10.1. Haemoglobin (Hb) > 10.0 g/dl 10.2. Neutrophils = 1.5 x 109/L 10.3. Platelets (Plts) = 100 x 109/L 11. Baseline liver function tests: 11.1. Serum bilirubin = 1.5 x upper normal limit 11.2. Serum alkaline phosphatase, alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST) 50ml/min (uncorrected value) or isotope clearance measurement > 50ml/min 13. 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 14.. Male patients must agree to use appropriate medically approved contraception during the study up to six months after the last vaccination 15. Lower age limit 18
Exclusion criteria
Exclusion criteria: 1. Receiving, or having received, chemotherapy or radiotherapy within 6 weeks of trial entry. 2. Having undergone surgery +/- PORT within 6 weeks of trial therapy 3. A negative result following anergy testing 4. Known chronic active infection with Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV) 5. Current active autoimmune disease 6. Current active skin diseases requiring therapy (psoriasis, eczema etc) 7. Ongoing active infection 8. History of anaphylaxis or severe allergy to vaccination 9. Previous myeloablative therapy followed by an autologous or allogeneic haematopoietic stem cell transplant 10. Patients who have had a splenectomy or splenic irradiation, or with known splenic dysfunction 11. Receiving current immunosuppressive medication, including corticosteroids within 4 weeks of the first dose 12. Pregnant and lactating women 13. Ongoing toxic manifestations of previous treatment 14. Major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not yet recovered 15. Patients with any other condition which in the investigator's opinion would not make the patient a good candidate for the clinical trial 16. Concurrent congestive heart failure or prior history of class III/ IV cardiac disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety 2. Occurrence of drug-related grade 3 or 4 systemic or local adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Immunity 2. Demonstration by ELISPOT assay of the frequency of IFN secreting lymphocytes recognising MHC class | — |
Countries
England, United Kingdom
Outcome results
None listed