Colorectal NeoplasmsPhase 2NCT00259844
Effect of TroVax in Patients Having Colorectal Cancer With Liver Metastases Removed
A Phase 2 study testing TroVax in people with Colorectal Neoplasms, run by Cancer Research UK.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- TroVax
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colorectal adenocarcinoma with metastases confined only to the liver, histologically proven and considered suitable for treatment by surgical resection.
- World Health Organisation (WHO) performance status of 0 or 1
- All toxic manifestations of previous treatment must have resolved. Exceptions to this are alopecia or certain Grade 1 toxicities which in the opinion of the Investigator and Cancer Research UK should not exclude the patient.
Who cannot join
- Radiotherapy, endocrine therapy, immunotherapy, systemic steroids, or chemotherapy during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the trial.
- Patients who are high medical risks because of non-malignant systemic disease, including those with active uncontrolled infection.
- Concurrent serious infections within the 28 days prior to entry to the trial
- Current malignancies at other sites, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
- Patients known to be serologically positive for Hepatitis B, C or HIV
- History of allergy to vaccinations or egg proteins.
Show all 9Show fewer
- Inflammatory bowel disease
- History of autoimmune disease
- Clinical evidence of cerebral metastases
About this study
Official title: A Phase 2 Study Immunologically Evaluating 5T4-MVA (TroVax) in Patients Undergoing Surgical Resection of Colorectal Liver Metastases
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.
Read the 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.
- Conditions
- Colorectal Neoplasms
- Being tested
- TroVax
- Keywords
- Colorectal, Liver Metastases, Vaccine, Colorectal Liver Metastases
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TroVaxBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Secondary outcomes (3)
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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startJun 2004
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Cancer Research UK
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford BioMedica
- Investigators
- Robert Hawkins, MD, Prof, Principal investigator, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259844
- Sponsor's protocol ID
- PH2/048
- Status last verified
- Nov 2005
- First submitted
- 29 Nov 2005
- Last updated
- 18 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study Immunologically Evaluating 5T4-MVA (TroVax) in Patients Undergoing Surgical Resection of Colorectal Liver Metastases
- ClinicalTrials.gov ID
- NCT00259844
- Acronym / sponsor ID
- PH2/048
- Conditions
- Colorectal Neoplasms
- Keywords
- Colorectal, Liver Metastases, Vaccine, Colorectal Liver Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Cancer Research UKUniversity, hospital or other
- Collaborators
- Oxford BioMedica
- Study start
- Jun 2004
- Study completion
- Dec 2006
- First posted
- 1 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Colorectal adenocarcinoma with metastases confined only to the liver, histologically proven and considered suitable for treatment by surgical resection.
- World Health Organisation (WHO) performance status of 0 or 1
- All toxic manifestations of previous treatment must have resolved. Exceptions to this are alopecia or certain Grade 1 toxicities which in the opinion of the Investigator and Cancer Research UK should not exclude the patient.
Key exclusion criteria (9 listed)
- Radiotherapy, endocrine therapy, immunotherapy, systemic steroids, or chemotherapy during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the trial.
- Patients who are high medical risks because of non-malignant systemic disease, including those with active uncontrolled infection.
- Concurrent serious infections within the 28 days prior to entry to the trial
- Current malignancies at other sites, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
- Patients known to be serologically positive for Hepatitis B, C or HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TroVax | Biological | – |
Primary outcome
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.
3 secondary outcomes
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Hawkins, MD, Prof principal investigator
The Christie NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TroVax in people with Colorectal Neoplasms, run by Cancer Research UK.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2006; AzTrials last refreshed its copy on 8 Nov 2026.