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Summary: Colorectal Cancer Vaccine Trial

Cancer of the colon and rectum is the second most common cancer in this country. The mainstay of treatment is surgical. However not all cases are suitable for surgery or recur afterwards. These patients are offered chemotherapy with or without radiotherapy that can control the disease for a period of time. Its ability to control the disease is not always long-lasting. Once the cancer 'escapes' control by chemotherapy, there is no treatment that prolongs survival.

The department of Oncology at St. George's Hospital has developed a cancer vaccine for the use in colorectal cancer. A vaccine in this sense, is a method of stimulating the immune system to fight the disease itself. The vaccine is produced from a number of colorectal cancer cell lines that are irradiated to make them inactive or an antibody that attacks colon cancer cells or the two combined. The vaccine is given into the skin, initially every 2 weeks for 6 weeks, then monthly for up to a year.

We are looking for 45 patients to participate in this trial. The patient must have been diagnosed with colon or rectal cancer and have been treated with chemotherapy, such as 5-fluorouracil injections or similar agents, but have evidence of progression, by a rising CEA or by X-ray or CT scan. They must be relatively fit, as there are frequent visits to St. George's Hospital. Patients must not be taking any other medications that may suppress the immune system, such as steroids, and not have been treated for any other cancer.

Patients will be monitored with regular out patients visits for symptoms, CEA level and measurements of the immune response to vaccination, as well as any side effects to vaccination. A similar approach in patients with the skin cancer, malignant melanoma, and prostate cancer has shown that side effects were minimal and these were usually skin itching and rashes related to the injections and 'flu-like symptoms.' We expect the side effects of this trial to be similar but we do not know exactly what side effects we will see following injection of this colorectal cancer vaccination.

Patient Inclusion/Exclusion Criteria

If you are eligible for this trial please contact your GP and ask to be referred to

Contact:

Dr. Fiona Lofts, Consultant Oncologist

St. George's Hospital
Blackshaw Road
Tooting, London, England, SW17 0QT
Telephone: +44 (0)20 8682 9131