A Phase II Trial to Assess TroVax® Plus Chemotherapy in Patients With Malignant Pleural Mesothelioma

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.

Conditions

• Malignant
• Pleural
• Mesothelioma

Interventions

BIOLOGICAL

TroVax®

Dose of 1 x 10\^9 TCID 50/ml, in 1ml, given on day 1 of weeks 1, 3, 6, 9, 12, 15, 18, 21, 24.

DRUG

Pemetrexed

500 mg/m\^2 over 10 mins, given on day 3 of weeks 4, 7, 10, 13.

DRUG

Cisplatin

75mg/m\^2 over 1 hour, given on day 3 of weeks 4, 7, 10, 13

DIETARY_SUPPLEMENT

Vitamin B12

1000μg intramuscular, Day 2 of weeks 3 and 12

DIETARY_SUPPLEMENT

Folic Acid

400μg oral daily from Day 2 of week 3 to Day 2 of week 16

DRUG

Dexamethasone

4mg BD, Days 2-6 of weeks 4, 7, 10, 13

Sponsors & Collaborators

• Velindre NHS Trust

  collaborator OTHER_GOV

• June Hancock Mesothelioma Research Fund

  collaborator UNKNOWN

• Velindre Cancer Centre Stepping Stones Appeal

  collaborator UNKNOWN

• Wales Cancer Trials Unit

  lead OTHER

Principal Investigators

• Jason F Lester, FRCR, MRCP · Velindre Cancer Centre

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2014-06-30

Completion

2014-12-31

Countries

• United Kingdom

Study Locations