A Phase II Trial to Assess TroVax® Plus Chemotherapy in Patients With Malignant Pleural Mesothelioma
Status:
Unknown status
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
This study is for patients with malignant mesothelioma of the lung lining (called pleura) who
are planning to have pemetrexed-cisplatin chemotherapy.
We are investigating whether giving a vaccine called TroVax® with pemetrexed-cisplatin
chemotherapy is both safe and potentially beneficial in patients with mesothelioma. This
vaccine has been used in combination with chemotherapy in other types of cancer and has been
shown to be safe. Cancer vaccines work by stimulating the person's immune system to fight the
disease, in a similar way to the immune system fighting infection. In laboratory experiments,
the vaccine has been shown to stimulate an immune response to a particular protein widely
found on mesothelioma cells called 5T4. In patients with mesothelioma it is hoped that the
vaccine will stimulate the immune system to attack mesothelioma cells carrying the 5T4
protein.
Pemetrexed-cisplatin chemotherapy is currently seen as the best treatment for patients with
mesothelioma, and this is why we plan to combine it with the vaccine. It is hoped that the
combination of the TroVax® vaccine and chemotherapy is more beneficial than chemotherapy
alone.
Pemetrexed-cisplatin will be given into a vein in the arm (intravenously) every 3 weeks. The
TroVax® vaccine will be given as an injection into the shoulder muscle (intramuscularly) 3
weeks before chemotherapy starts, one week before chemotherapy starts, then every 3 weeks.
Each participant will receive 4 chemotherapy and 9 vaccine treatments if they complete the
planned trial schedule. We aim to recruit 26 patients into the trial over a two year period.
If this study shows that pemetrexed-cisplatin chemotherapy plus the TroVax® vaccine is safe
and beneficial in terms of stimulating the immune system, the combination will be tested
further in larger clinical trials.
Phase:
Phase 2
Details
Lead Sponsor:
Wales Cancer Trials Unit
Collaborators:
June Hancock Mesothelioma Research Fund Velindre Cancer Centre Stepping Stones Appeal Velindre NHS Trust
Treatments:
Cisplatin Dexamethasone Folic Acid Hydroxocobalamin Pemetrexed Vitamin B 12