Locally advanced epithelial cancer of the head and neck. MedDRA version: 8.1 Level: LLT Classification code 10041823 Term: Squamous cell carcinoma
Conditions
Interventions
Product Name: ONCOVEXGM-CSF
Pharmaceutical Form: Solution for injection
Current Sponsor code: OncovexGM-CSF
Concentration type: range
Concentration number: 3 x 10e5 pfu/ml-2 x 10e6 pfu/ml
Product Na
Sponsors
BioVex Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Epithelial cancer of the head and neck, histologically proven, stage = N1 disease in the ipsilateral or contralateral sides of the neck. There should be at least one node with a diameter = 1 cm in diameter. 2. Aged 18 years or more. 3. Performance status (ECOG) 0,1. 4. Total white cell count = 3.0 x 10e9/L, platelet count = 80 x 10e9/L. 5. Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Undifferentiated Carcinoma of Nasopharyngeal Type (UCNT) WHO type III. 2. Pregnancy, lactation or lack of effective contraception in women of child-bearing potential (post-menopausal for =2 years; tubal ligation); lack of effective contraception in men if the partner is of child-bearing potential; women must have been practising an effective contraceptive method for at least three months prior to entry in to the trial (hormonal contraception or intrauterine device in conjunction with a barrier method). Men must use a condom or be surgically sterilised. 3. Concurrent chemotherapy with agents other than cisplatin or carboplatin 4. Surgery requiring general or spinal anaesthesia within the 14 days preceding entry to the trial. This does not include tumour biopsy or minor operations such as dental extraction 5. Intercurrent serious infections within the 28 days prior to entry to the trial. 6. Life threatening illness unrelated to cancer. 7. Treatment with antiviral agents at entry to the trial. 8. Uncontrolled congestive cardiac failure. 9. Clinically active autoimmune disease. 10. Active herpes labialis, other lesions due to HSV1 or dermatoses involving or within 50 cm of the lesions to be injected; active HSV1 lesions must have resolved before OncoVEXGM-CSF is injected. 11. Participation in a clinical trial within the previous four weeks. 12. Testing positive for HIV, hepatitis B or C or syphilis. 13. Hearing impairment. 14. History of allergic reaction to platinum or platinum containing compounds.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety of OncoVEXGM-CSF combined with chemoradiotherapy in patients with locally advanced cancer of the head and neck prior to radical neck dissection. ;Secondary Objective: To assess biological activity of the combination by computed tomography (CT) scanning, immunology testing and study of histopathology obtained at biopsy and at the time of surgery. ;Primary end point(s): •The primary end point will be tolerability of the combination of OncoVEXGM-CSF and chemoradiotherapy assessed in terms of adverse events and laboratory safety parameters. | — |
Countries
United Kingdom
Outcome results
None listed