Clinical trial sites are presently established in New York City; Washington DC; Philadelphia; Los Angeles; Birmingham, AL; Chicago; Dunmore, PA; Vancouver, BC; and Ottawa, Ontario. For more information about specific study locations and eligibility, individuals should contact Aventis Pasteur Limited, in Toronto, Canada at the following toll-free phone number: 1-866/455-0349.
The goal of the study is to determine if the vaccine, called ALVAC-CEA/B7.1, can activate the bodys own immune system to eliminate cancer cells that may not be eliminated with traditional treatment of metastatic colorectal cancer with the standard, first-line chemotherapy regimen, said Dr. Neil Berinstein, Assistant Vice President Clinical Oncology, Program Director, Cancer, Aventis Pasteur. We will be looking to see if the vaccine, combined with chemotherapy, allows a better outcome for patients than chemotherapy alone, he added.
- more - The multicenter trial, which is considered a pilot Phase II study to assess safety and immunologic activity, will randomly assign patients to one of three active treatment groups.
One study group will be vaccinated with ALVAC-CEA/B7.1 before starting standard chemotherapy and will receive additional, concurrent doses of the vaccine with the chemotherapy. Patients in another group will receive the same regimen described above plus doses of tetanus toxoid to determine whether this additional compound further enhances the immune response. Patients in the third group will receive stand
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