A Phase 2 Study Immunologically Evaluating 5T4-MVA (TroVax) in Patients Undergoing Surgical Resection of Colorectal Liver Metastases
18 Years
N/A
Both
Colorectal Neoplasms
Trial Information
A Phase 2 Study Immunologically Evaluating 5T4-MVA (TroVax) in Patients Undergoing Surgical Resection of Colorectal Liver Metastases
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.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Principal Investigator
Robert Hawkins, MD, Prof
Investigator Role:
Principal Investigator
Investigator Affiliation:
Christie Hospital NHS Foundation Trust
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
PH2/048
NCT ID:
NCT00259844
Start Date:
June 2004
Completion Date:
December 2006
Related Keywords:
- Colorectal Neoplasms
- Colorectal
- Liver Metastases
- Vaccine
- Colorectal Liver Metastases
- Neoplasms
- Colorectal Neoplasms
- Neoplasm Metastasis
- Liver Neoplasms
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