AN EXPLORATORY STUDY OF THE SAFETY AND BIOLOGICAL ACTIVITY OF ONCOVEXGM-CSF IN COMBINATION WITH RADIOTHERAPY AND CISPLATIN IN THE TREATMENT OF LOCALLY ADVANCED EPITHELIAL CANCER OF THE HEAD AND NECK

Phase 1

• Conditions: ocally advanced epithelial cancer of the head and neck.; MedDRA version: 8.1Level: LLTClassification code 10041823Term: Squamous cell carcinoma

• Registration Number: EUCTR2005-000777-21-GB
• Lead Sponsor: BioVex Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-13
• Study Completion: 2007-12-19
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 35

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 <1.5 X upper limit of normal (ULN).
6.Bilirubin less than 1.5 times the upper limit of the normal range, AST/ALT less than twice the upper limit of the normal range and alkaline phosphatase less than twice the upper limit of the normal range unless secondary to hepatic malignancy, in which case levels of 5 times the limit of the upper normal range are acceptable.
7.Able to give written informed consent and to comply with the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified