Table 2 Gene Therapy Advisory Committee approved clinical trials of gene therapy agents for head and neck squamous cell carcinoma in the UK.

Phase	Title		Gene	Gene type	Vector	Date/status
I	Gene directed enzyme prodrug therapy for the treatment of head and neck cancer		Nitroreductase	Tumour suppressor	Adenovirus	1999 open
I	A multiple ascending dose study evaluating the safety and gene transduction into malignant cells after administration of E1A–lipid complex by intratumoral injection with unresectable or metastatic head and neck tumours		E1A	Tumour suppressor	Lipofection	Withdrawn
II	Intravenous cisplatin, 5‐FU and intratumoral injection with ONYX‐015 into recurrent, chemotherapy naive squamous cell tumours of the head and neck		E1B deleted	Tumour suppressor	Adenovirus	1996 closed
I	Phase I study in patients with recurrent metastatic squamous cell carcinoma of the head and neck using SCH 58500 (rAd/p53)		P53	Tumour suppressor	Adenovirus	Never initiated
II	Preoperative intratumoral injection with an E1B attenuated adenovirus in patients with resectable head and neck tumours		E1B deleted	Tumour suppressor	Adenovirus	1999 closed
I	Open‐label, dose‐escalation trial of intra‐tumoral injection with an E1B attenuated adenovirus ONYX‐015, into recurrent and locally advanced p53(‐) squamous cell tumours of the head and neck		E1B deleted	Tumour suppressor	Adenovirus	1996 closed
II	Preoperative intratumoural injection with HSV1716 in patients with resectable squamous cell tumours of the head and neck		ICP34.5 deleted	Other	Herpes simplex virus	2001 open
I	First administration to man of an oncolytic herpes virus vector containing a transgene for granulocyte macrophage colony stimulating factor (Oncovex GM‐CSF)—a study of its safety, biodistribution and biological activity		ICP34.5 deletedICP47 deletedGranulocyte–macrophage colony stimulating factor (GM‐CSF)	Other	Herpes simplex virus	2001 open
I	Gene therapy for squamous cell head and neck cancer that has spread to the skin		Granulocyte–macrophage colony stimulating factor (GM‐CSF)	Cytokine	Herpes simplex virus	2002 open
I	A recombinant vaccinia Ankara (MVA) based vaccine encoding Epstein‐Barr virus (EBV) target antigens: phase I dose escalation trial to determine immunogenicity and toxicity in patients with EBV + nasopharyngeal malignancy		Epstein‐Barr virus epitopes (EBNA1 and LMP2A)	Other	DNA + MVA	2002 open