TeloVac Trial
Background
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.
Study Design
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.
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}.
Hypothesis to be tested
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
Trial management
Trial sponsor is the Royal Liverpool and Broadgreen University Hospitals NHS Trust. Chief Investigator is Dr Gary Middleton, Royal Surrey County Hospital NHS Trust. The trial will be centrally co-ordinated by the Cancer Research UK Liverpool Cancer Trials Unit and any queries should be directed here (please see contact page)
Latest Update
For more information on the TeloVac trial please visit the Cancer help website.
www.cancerhelp.org.uk/trials/trials/trial.asp?=&trialno=9724
Download TeloVac information leaflet
Open sites
Sites expressed interest
