A Phase I intratumoural trial of Coxsackievirus A21 (CAVATAK) in late stage Head and Neck Cancer patients
- Conditions
- Head and Neck Squamous Cell CarcinomaCancer - Head and neck
- Registration Number
- ACTRN12609000277246
- Lead Sponsor
- Viralytics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 9
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: Patients will be monitored by the trial investigators for vital signs, blood chemistry, haematology, Electrocardiogram (ECG) and adverse events.[Patients will be monitored by 11 visits over 127 days post treatment]
- Secondary Outcome Measures
Name Time Method Size of the injected tumour and non-injected tumours will be measured in each patient to assess the effect of the treatment against the Response Evaluation Criteria in Solid Tumours (RECIST) criteria[Patients will be monitored by 11 visits over 127 days post treatment]