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Note of the 29th Meeting
of the Gene Therapy Advisory Committee (GTAC) held on 11 October 2000.
Present:
Professor Norman C Nevin (Chair),
Professor Anthony J Pinching,
Professor Patrick Johnston,
Dr Sohaila Rastan,
Reverend Dr Lee Rayfield,
Dr Andrew Lever,
Dr David Crosby,
Professor James Neil,
Professor David Harrison,
Mr Michael Harrison,
Ms Caroline Benjamin,
Professor Alex Markham,
Professor Ian Hart,
Dr Brian Davis (MCA),
Dr Elaine Godfrey (MCA).
Secretariat:
Dr Jayne Spink,
Mrs Margaret Straughan,
Mrs Beryl Keeley.
Observer:
Dr Elaine Gadd (DH)
1. Welcome and Apologies.
The Chairman announced that members should declare any conflict of interest
in assessing any clinical trial proposal. He informed members that Dr.
Mark Bale was leaving the GTAC to take up the role of secretary with the
Human Genetics Commission and that Dr. Jayne Spink was now Team Leader
and Secretary of GTAC and the Genetcis and Insurance Committee. The chairman
also welcomed Mr. David Crosby, a retired surgeon. Apologies had been
received from Mrs. Ann Hunt, Mrs. Rosie Barnes and Mrs. Irene Train.
2. Minutes of the 28th
Meeting.
These had been circulated and with minor amendments, were accepted as
a true record.
3. Matters Arising.
3.1 Bladder Cancer protocol.
Conditional approval was granted at the last meeting and the secretariat
met with the proposers to discuss the ammendments.
3.2 Guidance Notes.
Members were asked for their comments on the new draft guidance for proposers
of gene therapy trials. Their suggestions would then be included with
the new guidance notes, which would be published with the sixth annual
report.
3.3 Update from MCA regarding
Clinical Trials Directive.
The committee was informed of the current state of progress in drafting
the European Directive on Good Clinical Practice and Clinical Trials,
which started its second reading in the European Parliament in September.
4. Protocol: A Study of
the Safety of modified Herpes simplex virus (HSV1716) when injected into
tumour bearing brain following resection of recurrent or newly diagnosed
high grade glioma. Beatson Oncology Centre, Glasgow.
The chairman summarised the background to this project, which has proceeded
in a stepwise fashion. The chairman also informed the members that early
phases on this project had yielded encouraging results. The current protocol
was favourably reviewed by an external referee. Conditional approval was
granted subject to clarification of treatment regimes and the patient
information leaflet. It was agreed that the secretariat would meet with
the proposers to discuss the issues raised in committee.
5. Protocol: The treatment
of leukaemia relapse after allogenic stem cell transplantation by HSV-tk
transduced donor lymphocyte transfusions. Hammersmith Hospital.
The chairman explained the background to the proposed study. Host versus
Graft Disease (GvHD) can be a complication in allogenic Bone Marrow Transplantation
(BMT) and Donor Lymphocyte Infusion (DLI). Immunosuppressive therapy used
to treat GvHD may also affect the ability of the graft to eliminate residual
cancer cells or may open up the patient to infection. Following discussion
by members, it was agreed to give conditional approval to this study subject
to inclusion of several items in the patient information leaflet and protocol
text.
6. Protocol: A phase I/II
study of polyHer2 neu vaccine in the treatment of epithelial tumours.
St. James Hospital, Leeds.
The chairman explained to the members that this trial involved the use
of a DNA vaccine expressing a protein often seen in human epithelial tumours.
Patients would be those with metastatic breast cancer who are not to receive
conventional treatment. Given certain concerns and the fact that a new
pharmaceutical treatment would soon be available, the proposal was rejected.
7. Presentation by The Wellcome
Trust.
Representatives from the Wellcome Trust joined the committee to discuss
preliminary results of a deliberatvie panel established by the Trust.
This panel examined issues surrounding public perceptions of genetics
and gene therapy. GTAC also participiated in the Trusts' initiative. Preliminary
results were reported to the committee. A final report from the Trust
is expected in early 2001.
8. Any Other Business.
8.1 Cancer Gene Therapy
Protocols.
A discussion took place with regard to the specificity of patient groups
in cancer trials. While GTAC has argued for studies to be carried out
within specific tumour categories, members agreed that GTAC should not
be constrained by precedent but rather reflect the changing nature of
gene therapy research. It was agreed that in phase I trials patients with
a range of tumour types could be recruited, but that phase II studies
should be tumour-specific.
8.2 SAE Report.
The Chairman noted that the numbers of Serious Adverse Events reported
in gene therapy trials had increased as a result of a trial associated
death in the US.
8.3 Open Meeting 2001.
The committee was informed of plans to host a GTAC workshop entitled "Gene
Therapy for Inherited Disorders," to be held at Colindale, London, on
2 March 2001.
8.4 December Meeting.
The committee was informed that the secretariat had received eight new
protocols and these would be considered over a two-day meeting in December.
Dates for meetings in 2001 of 14 February, 9 May, 25 July, 10 October
& 12 December were arranged.
IMPORTANT NOTE.
All gene therapy is research and recruitment of patients into research
trials takes place under strict rules set out by GTAC, under principles
elaborated by professional bodies and only after review of clinical protocols
by GTAC.
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