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Patients are
currently being enrolled in a multicenter phase II clinical trial
of a therapeutic vaccine designed to be used with chemotherapy
in treating advanced colorectal cancer.
"The goal
of the study is to determine if the vaccine, called ALVAC-CEA/B7.1,
can activate the body's 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 at Aventis Pasteur.
"We will be
looking to see if the vaccine, combined with chemotherapy, allows
a better outcome for patients than chemotherapy alone," Berinstein
said.
The trial
will enroll up to 90 patients with metastatic colorectal cancer
not yet treated with standard chemotherapy. Participants will
be randomly assigned to one of three treatments.
Group one
will be vaccinated with ALVAC-CEA/B7.1 before starting standard
chemotherapy and will receive additional doses of the vaccine
along with the chemotherapy.
The second
group will receive the same treatment as group one plus doses
of tetanus toxoid to determine whether this additional compound
further enhances the immune response.
The third
group will receive standard chemotherapy and, if they achieve
complete or partial responses, they will have the option of receiving
ALVAC-CEA/B7.1 vaccine upon completion of chemotherapy.
Treatments
will last about 28 to 31 weeks, depending on the group and how
well patients tolerate the chemotherapy. For more information,
contact Aventis Pasteur: 1- 866-455-0349.
Other
Sources: Aventis Pasteur
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