Studies of a new treatment strategy for
colorectal cancer using a therapeutic cancer vaccine technology have begun
enrolling patients at several trial sites around the United States and Canada.
The trial will enroll up to 90 patients with metastatic colorectal cancer who
have not yet received treatment with standard chemotherapy, according to Aventis
Pasteur Limited of Toronto, Canada, the study sponsor.
"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 using the standard, first-line chemotherapy regimen,"
said Dr. Neil Berinstein, assistant vice president, clinical oncology, and
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.
The multicenter, pilot phase II trial is designed to assess
safety and immunologic activity, and will randomly assign patients to one of
three treatment groups. One group will be vaccinated with ALVAC-CEA/B7.1 before
beginning standard chemotherapy (with irinotecan [CPT-11, Camptosar],
fluorouracil [5-FU], and leucovorin) and will receive additional, concurrent
doses of the vaccine with the chemotherapy. 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. The third group will
receive standard chemotherapy; patients in this group who achieve complete or
partial responses will have the option of receiving the ALVAC-CEA/B7.1 vaccine
upon completion of the chemotherapy.
Treatment will require approximately 28 to 31 weeks, depending
on which group patients are assigned to and how well they tolerate the
chemotherapy regimen. Patients will be evaluated routinely for local and
systemic adverse events immediately following treatment and at each follow-up
visit. Immune response and efficacy measures for objective response and response
duration will also be assessed at several predesignated points during treatment
and at the end of the study.
Clinical trial sites have been established in New York;
Washington, DC; Philadelphia; Los Angeles; Birmingham, Ala; Chicago; Dunmore,
Pa; Vancouver, BC; and Ottawa. For more information about specific study
locations and eligibility contact Aventis Pasteur Limited in Toronto at