Effect of TroVax in Patients Having Colorectal Cancer With Liver Metastases Removed

NCT00259844 | Completed Phase 2

• 1 other identifier: PH2/048
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Neoplasms

Keywords

Colorectal; Liver Metastases; Vaccine; Colorectal Liver Metastases

Outcome Measures

Primary Outcomes (2)

• 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).

Interventions

TroVax BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Research UK: lead
• Oxford BioMedica: collaborator

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

TroVax

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Robert Hawkins, MD, Prof

  The Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 29, 2005
• First Posted: December 1, 2005
• Study Start: June 1, 2004
• Study Completion: December 1, 2006
• Last Updated: July 18, 2006

Record last verified: 2005-11