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Present: Professor Norman Nevin (Chair), Professor Terry Hamblin, Professor Jim Neil, Rev Dr Lee Rayfield, Dr Adrian Lepper, Dr Richard Ashcroft, Professor Andrew Lever, Mr Michael Harrison, Dr Peter Harris, Professor David Harrison and Dr Michael Waterhouse. Secretariat: Dr Monika Preuss, Dr Jayne Spink, Mr Daniel Gooch. Item 1: Welcome The Chair welcomed the Committee to its fourth meeting of 2004, held in the Fellows' room at King's College Cambridge. The Chair was pleased to note that the Public Meeting "Decoding
Childhood Gene Therapy" held the previous day had attracted almost
90 people with excellent feedback. Item 2: Minutes of the 48th meeting of GTAC The minutes were agreed as an accurate and true record of the meeting. Item 3: Matters Arising The several letters sent out concerning correspondence arising from the
last meeting did not give rise to any substantial discussion. Item 4: GTAC 074: A randomised efficacy trial of HSV1716 in patients with recurrent glioblastoma multiforme This is a large efficacy trial of HSV1716 in patients with glioblastoma
multiforme, a highly malignant brain tumour. Current treatment consists
of surgery followed by radio- and chemotherapy; still, the outlook for
patients is very grim. The median survival for patients can be less than
one year. HSV1716 is a modified form of herpes simplex virus which cannot
infect cells that are not themselves rapidly dividing. However, HSV1716
can infect dividing tumour cells which leads to cell death. The study
aims to assess the efficacy of HSV1716 administered by multipoint microinjection
or convection enhanced delivery. One hundred patients with residual or
recurrent glioblastoma multiforme will be randomised to receive HSV1716
treatment or chemotherapy. After some discussion with the proposers, GTAC
decided to approve the study subject to a few minor points on the protocol
and PIL being addressed. Item 5: Chairman's Actions Since the last GTAC meeting, eight Chairman's Actions had been taken,
none of which gave rise to any substantial discussion. Item 6: SAE update A summary of all SAEs was given, focussing on those trials for which
new SAEs were received. These gave no rise for concern. Item 7: Pre-proposal: Gene therapy trial for CF in children A pre-proposal has been received for a phase I trial for CF in children
to discuss with GTAC the ethics of recruiting children into this study.
Cystic Fibrosis is caused by mutations in the Cystic Fibrosis Transmembrane
Conductance Regulator gene (CFTR) which transports salts and water in
and out of the cells that line the digestive and respiratory systems.
The proposers aim to deliver to the nasal epithelium of children a vector
which consists of a plasmid-borne CFTR gene. The proposers joined the
Committee for a presentation and Q&A session. Following correspondence with the ABI about HIV gene therapy trials,
the ABI sent, for information, its consultation document on HIV and insurance.
The Committee briefly discussed the paper. Item 9: Any other business A document supplied by the MRC on guidance for researchers working with
children was tabled. The Committee briefly discussed the paper. Next meeting: Wednesday, 15 September in Skipton House, London GTAC Secretariat
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