None listed
Conditions
Brief summary
This study assesses the safety and effectiveness of intratumoural CAVATAK treatment of squamous cell carcinoma (SCC) of the head and neck. Patients can join the study where: - they have recurring or relapsed SCC after standard chemotherapy, - their tumour cells are shown to bear ICAM-1 receptors. Patients will receive one, three or six doses of CAVATAK injected directly into a tumour. the injected tumour and other non injected tumours will be measured by calipers and CT scans to assess the effect of the treatment. Patients will be monitors for 127 days after treatment. CAVATAK is a benign cancer killing virus that preferentially attacks tumour cells that are expressing the ICAM-1 receptor. The aim of the study is to investigate the safety and effectiveness of CAVATAK in the treatment of head and neck cancer
Interventions
Patients will receive an intratumoural dose of CAVATAK estimated to be 30% of the injected tumour volume, with a maximum dose of 2mL. All doses will be 10^9 50% Tissue Culture Infectivity Dose (TCID50). The first cohort of patients will receive one dose, the second cohort will receive 3 doses 48 hours apart and the third and final cohort will receive 6 doses 48 hours apart.
Sponsors
Viralytics Limited
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who are willing and able to provide written informed consent to participate in the study. Patients with histologically confirmed metastatic or recurrent squamous cell carcinoma of the head or neck currently documented as “progressive disease”. Head and neck cancer patients with at least one tumour mass where the tumour mass is accessible for intratumoural injection and can be measured at periodic intervals for tumour size using callipers and/or ultrasound. All patients to have histologically confirmed squamous cell carcinoma of the head and neck (excluding nasopharyngeal) that had recurred or relapsed after surgery and/or radiotherapy and/or chemotherapy. The longest diameter of the target injectable tumour being no greater than 6 cm or no less than 1 cm in the longest diameter. The tumour mass to be intratumourally injected to be easily accessible for injection and amenable to measurement by physical examination and / or radiographically. Patients to be 18 years or older Absence of circulating antibodies to CVA21 (titre < 1:16). Adequate haematological, hepatic and renal function, defined as: ANC > 1.5 x 109/L, platelets > 100 x 109/L Bilirubin < 20umol/L, AST < 2.5 times the upper limit of normal Calculated creatinine clearance > 30 mL/minute Adequate immunologic function, defined as: Serum IgG > 5g/L T cell subsets within normal limits Fertile males and females must agree to the use of an adequate form of contraception. Hormonal contraceptives should be supplemented with an additional barrier method. Negative pregnancy test is required in female patients of child-bearing potential.
Exclusion criteria
Patients receiving radiotherapy to the proposed injected tumour or radiotherapy within the last 3 weeks Performance status > 1 on the Eastern Cooperative Oncology Group (ECOG) scale Life expectancy < 6 months. Pregnancy or breastfeeding. Primary or secondary immunodeficiency, including immunosuppressive disease, and immunosuppressive doses of corticosteroids (e.g. prednisolone > 7.5mg per day) or other immunosuppressive medications including cyclosporine, azathioprine, interferons, within the past 4 weeks. Positive serology for Human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C. Splenectomy. Presence of uncontrolled infection. Any uncontrolled medical condition that in the opinion of the Investigator is likely to place the patient at unacceptable risk during the study or reduce their ability to complete the study Participation in another study requiring administration of an investigational drug or biological agent within the last 4 weeks Known allergy to treatment medication or its excipients
Outcome results
None listed