Effect of TroVax in Patients Having Colorectal Cancer With Liver Metastases Removed
This study will test the safety and efficacy of TroVax in patients undergoing surgical resection of colorectal cancer with liver metastases.
TroVax potentially works by encouraging the immune system to react against the 5T4 protein on the surface of bowel cancer cells. The immune system is then able to recognise 5T4 and kill cells that carry it. The hope is that if tumour cells started to grow again after the main tumour has been surgically removed, the immune system would be able to find and destroy them.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study Immunologically Evaluating 5T4-MVA (TroVax) in Patients Undergoing Surgical Resection of Colorectal Liver Metastases|
- To characterise and quantify the immune response to the oncofetal antigen 5T4 locally in peripheral blood, modified by vaccination with TroVax before resection of colorectal adenocarcinoma liver metastases.
- To evaluate the safety, toxicity and tolerability of the TroVax vaccine in this setting.
- To characterise and quantify the immune response to the oncofetal antigen 5T4 locally in tumour.
- To review any further effect on immunity by TroVax vaccinations following surgery.
- To monitor and collect data on clinical outcomes (time to progression/relapse/death).
|Study Start Date:||June 2004|
|Estimated Study Completion Date:||December 2006|
Treatment of metastatic colorectal cancer depends on the site of disease. The prognosis for patients is poor although cure can be obtained if disease is localised and operable. Patients with metastatic disease confined to the liver may achieve a cure rate of between 20% and 60% if these metastases are resited, but there is a risk that micrometastatic disease will persist post-operatively.
TroVax consists of a highly attenuated vaccinia virus (modified vaccinia Ankara) containing the human tumour associated antigen ST4.
The human oncofetal antigen 5T4 a surface glycoprotein expressed by placental tissue, but also by a wide range of human carcinomas including most colorectal and renal carcinomas. 5T4 exhibits only low level expression in normal tissue and is thus a suitable target for immune therapy of cancer.
This study will evaluate for the first time in man the immunological effects of the TroVax vaccine locally within a target tumour and in peripheral blood. Tolerability of the vaccine will also be assessed.
Patients receive 2 intramuscular injections of TroVax at a 2 week interval followed by surgery 10 days later. Two further vaccinations are given at 4 and 8 weeks after surgery. Patients who show a response to the first four vaccinations are given 2 additional vaccinations 20 and 28 weeks post surgery.