Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00259844
Status:
COMPLETED
Last Update Posted:
2006-07-18
First Post:
2005-11-29
Brief Title:
Effect of TroVax in Patients Having Colorectal Cancer With Liver Metastases Removed
Sponsor:
Cancer Research UK
Organization:
Cancer Research UK
Study Overview
Official Title:
A Phase 2 Study Immunologically Evaluating 5T4-MVA TroVax in Patients Undergoing Surgical Resection of Colorectal Liver Metastases
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None