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TeloVac   

Title

A prospective, phase III, controlled, multicentre, randomised clinical trial comparing combination gemcitabine and capecitabine therapy with concurrent and sequential chemoimmunotherapy using a telomerase vaccine in locally advanced and metastatic pancrea


Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
III Treatment Closed Over 18 The Royal Liverpool and Broadgreen University Hospitals NHS Trust Eudract No: 2006-000461-10
Isrctn No: 43482138

Purpose

Telomerase is a ribonucleoprotein enzyme which is involved in the DNA replication of the cell cycle. The enzyme is over-expressed in majority of human cancers including 90% of advanced pancreatic cancer patients and therefore is a natural therapeutic target in the treatment of cancer.
The over-expression of Telomerase enables the cancer cells to overcome mortality and therefore be a major contributing factor to progression of cancer. Telomerase is one of the body's own proteins and therefore not recognised or attacked by the immune response. The GV1001 vaccine targets the over-expressed telomerase by enabling the immune response to recognise the enzyme and illicit an immune response against it. As telomerase is over expressed in majority of cancers and plays a leading role in the mortality of cancer cells, GV1001 could in future become a common cancer vaccine.


Trial Lead Organisations

  • Royal Liverpool and Broadgreen University Hospitals NHS Trust
  • Chief Investigator: Dr Gary Middleton, Royal Surrey County Hospital NHS Trust


Trial Start Date

03/06/2007


Trial Coordinator

Gemma Nanson


Trial Coordinator Email Address

g.simpson@liv.ac.uk


Trial Coordinator Contact No

0151 794 8974


Website Treatment  

This study is designed as a prospective, phase III, controlled, open label, multicentre, randomised clinical trial comparing combination Gemcitabine and Capecitabine therapy with concurrent and sequential immunotherapy using the telomerase vaccinne GV 1001 in locally advanced and metastatic pancreatic cancer. Patients will be treated until disease progression and will be subject to follow-up until death. Patients will be randomised equally between the three arms:
  • Gemcitabine & Capecitabine
  • Gemcitabine and Capecitabine then sequential GV1001 followed by further Gemcitabine and capecitabine for patients where no progressive disease (PD) was demonstrated upon the week 8 CT Concurrent administration of Gemcitabine and Capecitabine and GV1001.
  • Concurrent administration of Gemcitabine and Capecitabine and GV1001

Patients will be stratified by: Stage of disease (locally advanced vs. metastatic) and Performance status (0 versus 1 versus 2)

Target recruitment is 1110 patients (370 within each arm).

The Capecitabine will be fully funded by Roche Pharmaceuticals and will be distributed free of charge. See BJC paper-for phase I/II full paper {ref: CTN 1-2000 BJC paper.pdf}.

Trial Endpoints  


Primary Outcome  

  • Length of survival


Secondary Outcomes  

  • Time to progression
  • Quality of life
  • Clinical Benefit Response
  • Objective response rate
  • Toxicity
  • Survival and response by DTH
  • CA19-9 over time

Eligibility  

Main Criteria for Inclusion:

  • Age > 18 years.
  • Histologically or cytologically proven pancreatic ductal adenocarcinoma carcinoma or undifferentiated carcinoma of the pancreas.
  • Locally advanced or metastatic disease precluding curative surgical resection or patients who have relapsed following previously resected pancreatic cancer
  • Contrast enhanced CT scan of the thorax, abdomen and pelvis within 28 days (and up to a maximum of 32 days) prior to commencing treatment.
  • (Patients who are unable to receive contrast(due to allergies etc) may still be eligible for the trial provided the CT scan still demonstrates measurable disease. Also if, in exceptional circumstances, it is not possible to include a CT scan of the pelvis the patient may still be enrolled into the study. In this instance, no subsequent pelvic CT scans will need to be performed.)
  • Unidimensionally measurable disease (from CT scan) in accordance with the RECIST guidelines (Version ?; Appendix 2).
  • ECOG performance status 0, 1 or 2.
  • Platelets=100 x 109/l; WBC = 3 x 109/l; neutrophils = 1.5 x 109/l at entry.
  • Serum bilirubin = 35 ?mol/l
  • Calculated creatinine clearance over 50ml/min according to Cockcroft & Gault.
  • Life expectancy > 3 months.
  • Fully informed written consent given.

Main Criteria for Exclusion:

  • Medical or psychiatric conditions compromising informed consent.
  • Intracerebral metastases or meningeal carcinomatosis.
  • Clinically significant serious disease or organ system disease not currently controlled on present therapy.
  • Uncontrolled angina pectoris.
  • Pregnancy or breast feeding.
  • Previous chemotherapy for locally advanced and metastatic disease. Previously adjuvant chemotherapy for resected pancreatic cancer will be permitted providing chemotherapy was completed more than 12 months previously.
  • Radiotherapy within the last 4 weeks prior to start of study treatment.
  • Concurrent malignancies or invasive cancers diagnosed within the past 5 years except for adequately treated Basal Cell Carcinoma of the skin, in situ carcinoma of the uterine cervix or resected pancreatic cancer (see Exclusion Criteria: number 6 andInclusion Criteria: number 3)
  • Known malabsorption syndromes.
  • Patients with a known hypersensitivity to any of the investigational products or patients with a dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Medication which might affect immunocompetence e.g. chronic treatment with long term steroids or other immunosuppressant for an unrelated condition. Patients will be eligible if they have been receiving short term steroids for palliation of cancer related symptoms.
  • All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom.

UK: ENGLAND

  • Barnstaple, North Devon District Hospital (Barnstaple) (Mark Napier)
  • Basingstoke, North Hampshire NHS Trust (Basingstoke) (Charlotte Rees)
  • Boston, Pilgrim Hospital (Boston) (Zuzana Stokes)
  • Bournemouth, The Royal Bournemouth Hospital (Tamas Hickish)
  • Brighton, Sussex Oncology Centre (Brighton) (Andrew Webb)
  • Bristol, Bristol Haematology and Oncology Centre (Stephen Falk)
  • Cambridge, Addenbrooke's Hospital (Cambridge) (Pippa Corrie)
  • Carlisle, Cumberland Infirmary (Carlisle) (Jonathan Nicoll)
  • Carlisle, West Cumberland Hospital (Carlisle) (Jonathan Nicoll)
  • Chelmsford, Mid Essex Hospital (Chelmsford) (Saad Tahir)
  • Dartford, Darent Valley Hospital (Dartford) (Riyaz Shah)
  • Dorchester, Dorset County Hospital (Dorchester) (Richard Osborne)
  • Exeter, Royal Devon & Exeter Hospital (Elizabeth Toy)
  • Great Yarmouth, James Paget Hospital (Great Yarmouth) (Ulrike Dernedde)
  • Guildford, Royal Surrey County Hospital (Guildford) (Sebastian Cummins)
  • Guildford, Royal Surrey County Hospital (Guildford) (Gary Middleton)
  • Huddersfield, Huddersfield Royal Infirmary (Jo Dent)
  • Ipswich, Ipswich Hospital (Rubin Soomal)
  • Leeds, St. James's University Hospital (Leeds) (Alan Anthoney)
  • Leicester, Leicester Royal Infirmary (Will Steward)
  • Lincoln, Lincoln County Hospital (Zuzana Stokes)
  • Liverpool, Royal Liverpool University Hospital (Adrian Moss)
  • London, Guy's & St Thomas' Hospital (London) (Paul Ross)
  • London, Royal Free Hospital (London) (Tim Meyer)
  • London, Royal Marsden Hospital (London) (David Cunningham)
  • London, St. Bartholomew's Hospital (London) (David Propper)
  • London, St. George's Hospital (London) (Tim Benepal)
  • Manchester, The Christie (Manchester) (Juan Valle)
  • Middlesbrough, James Cook University Hospital (Middlesborough) (Nick Wadd)
  • Newcastle Upon Tyne, Sir Bobby Robson Cancer Trials Research Centre (Newcastle) (Fareeda Coxon)
  • Northwood, Mount Vernon Cancer Centre (Northwood) (Mark Harrison)
  • Norwich, Norfolk and Norwich University Hospital (Tom Roques)
  • Oxford, Churchill Hospital (Oxford) (Kinnari Patel)
  • Peterborough, Peterborough District Hospital (Karen McAdam)
  • Poole, Poole Hospital NHS Trust (Richard Osborne)
  • Portsmouth, Portsmouth Haemotology & Oncology Centre (Caroline Archer)
  • Salisbury, Salisbury District Hospital (Tim Iveson)
  • Sheffield, Weston Park Hospital (Sheffield) (Jonathan Wadsley)
  • Slough, Wexham Park Hospital (Slough) (Maher Hadaki)
  • Southampton, Southampton University Hospital (Tim Iveson)
  • St. Leonards on Sea, Sussex Cancer Research Network (Angus Robinson)
  • Sutton, Royal Marsden Hospital (Sutton) (David Cunningham)
  • Torquay, Torbay District General Hospital (Torquay) (Rajaguru Srinivasan)
  • Truro, Royal Cornwall Hospital (Truro) (Richard Ellis)
  • Weston-super-Mare, Weston General Hospital (Weston-super-Mare) (Serena Hilman)
  • Wirral, The Clatterbridge Cancer Centre (Wirral) (Olusola Faluyi)
  • Worthing, Worthing Hospital (Andrew Webb)
  • Wrexham c/o Rhyl, Wrexham Maelor Hospital (Simon Gollins)
  • Yeovil, Yeovil District Hospital (Erica Beaumont)

UK: N. IRELAND

  • Belfast, Belfast City Hospital (Martin Eatock)

UK: SCOTLAND

  • Aberdeen, Aberdeen Royal Infirmary (Marianne Nicolson)
  • Glasgow, The Beatson West of Scotland Cancer Centre (Glasgow) (Jeff Evans)

UK: WALES

  • Rhyl, Glan Clwyd Hospital (Rhyl) (Angel Garcia-Alonso)

UK: ENGLAND

  • Basildon, Basildon and Thurrock University Hospital (Pauline Leonard)
  • Birmingham, Heartlands Hospital (Birmingham) (Joyce Thompson)
  • Birmingham, Queen Elizabeth Hospital (Birmingham) (Daniel Palmer)
  • Canterbury, Kent and Canterbury Hospital (Justin Waters)
  • Cheltenham, Cheltenham General Hospital (Charles Candish)
  • Coventry, University Hospital Coventry & Warwickshire NHS Trust (Sharmila Sothi)
  • Derby, Derbyshire Royal Infirmary (Rajendra Kulkarni)
  • Dudley, Russells Hall Hospital (Dudley) (David Ferry)
  • Gloucester, Gloucestershire Royal Hospital (Gloucester) (Charles Candish)
  • Harlow, Princess Alexandra Hospital (Harlow) (John Bridgewater)
  • Hereford, Hereford County Hospital (Nick Reed)
  • Keighley, Airedale General Hospital (Keighley) (Michael Crawford)
  • London, North Middlesex Hospital (London) (John Bridgewater)
  • London, University College Hospital (London) (John Bridgewater)
  • Maidstone, Maidstone Hospital (Justin Waters)
  • Northampton, Northampton General Hospital (K Patel)
  • Northampton, Northampton General Hospital (Somnath Mukherjee)
  • Plymouth, Derriford Hospital (Plymouth) (Sarah Pascoe)
  • Preston, Royal Preston Hospital (Ajay Mehta)
  • Reading, Royal Berkshire Hospital (Reading) (Jocelyn Adams)
  • Stafford, Staffordshire General Hospital (Fawzi Adab)
  • Stoke-on-Trent, University Hospital Of North Staffordshire (Fawzi Adab)
  • Taunton, Musgrove Park Hospital (Taunton) (Julie Walther)
  • Walsall, Manor Hospital (Walsall) (Andrew Hartley)
  • Westcliff-on-Sea, Southend Hospital (Westcliff-on-Sea) (Pauline Leonard)
  • Wirral, Southport and Formby District General Hospital (Amanda Jones)
  • Wolverhampton, New Cross Hospital (Wolverhampton) (David Ferry)
  • Worcester, Worcestershire Royal Hospital (Worcester) (Charles Candish)
  • York, York Hospital (David Jackson)

UK: WALES

  • Cardiff, Velindre Hospital (Cardiff) (Somnath Mukherjee)
  • Swansea, Singleton Hospital (Swansea) (Colin Askill)

Interactive Map  

To find out more information about a hospital within your area click on the pin.


View TeloVac Participating Centres in a larger map

Frequently Asked Questions  

Q. If I have received chemotherapy before, am I eligible for the TeloVac trial?

Unfortunately any history of previous chemotherapy (including gemcitabine and/or capecitabine) excludes patients from the trial as it may affect the outcome of the trial.

Q. My hospital is not involved in the TeloVac trial, what can I do?

Ask your consultant to find the closest hospital involved in the TeloVac trial and discuss your options of being transferred.

Q. If I have had surgery (resection), am I eligible?

The tumour must be inoperable at the time of study screening. This can either be the tumour which was first diagnosed or a tumour that has progressed since previous surgery for pancreatic cancer.

Q. How many people have received the vaccine? How safe is it?

To date, more than a 100 patients have been vaccinated with GV1001 either alone or in combination with a shorter peptide that activates cytotoxic T-cells. The overall safety picture emerging from early phase I/II trials is that GV1001 can be administered safely to human subjects.

Q. What are the side effects of the vaccine?

Side effects of the vaccine that you may encounter are:

  • mild temporary pain or rash at the injection site should be expected
  • Flu like symptoms e.g. muscle aches and pains and a temperature. Paracetamol usually controls this.

Q. Why did you choose this specific therapeutic target for the vaccine?

Telomerase is a ribonucleoprotein enzyme which is involved in the DNA replication of the cell cycle. The enzyme is over-expressed in majority of human cancers including 90% of advanced pancreatic cancer patients and therefore is a natural therapeutic target in the treatment of cancer.

The over-expression of Telomerase enables the cancer cells to overcome mortality and therefore be a major contributing factor to progression of cancer. Telomerase is one of the body's own proteins and therefore not recognised or attacked by the immune response. The GV1001 vaccine targets the over-expressed telomerase by enabling the immune response to recognise the enzyme and illicit an immune response against it. As telomerase is over expressed in majority of cancers and plays a leading role in the mortality of cancer cells, GV1001 could in future become a common cancer vaccine.

Links  

../docs/Leaflets/telovac.pdf#TeloVac Leaflet, ../crfs/login.asp#Download CRFs (login required)