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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
HPV-16 +ve Oropharyngeal Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Description:

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

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Terence Jones, BSc,FRCS,MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Liverpool

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

ISRCTN47069182

NCT ID:

NCT01598792

Start Date:

February 2012

Completion Date:

October 2014

Related Keywords:

  • HPV-16 +ve Oropharyngeal Carcinoma
  • Carcinoma
  • Oropharyngeal Neoplasms

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