Status:
COMPLETED
Effect of TroVax in Patients Having Colorectal Cancer With Liver Metastases Removed
Lead Sponsor:
Cancer Research UK
Collaborating Sponsors:
Oxford BioMedica
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 metastati...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Inflammatory bowel disease
- History of autoimmune disease
- Clinical evidence of cerebral metastases
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00259844
Start Date
June 1 2004
End Date
December 1 2006
Last Update
July 18 2006
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