Novel Colorectal Cancer Trial Seeks Patient Volunteers at Leading Cancer Centers

Studies of a new treatment strategy forcolorectal cancer using a therapeutic cancer vaccine technology have begunenrolling patients at several trial sites around the United States and Canada.The trial will enroll up to 90 patients with metastatic colorectal cancer whohave not yet received treatment with standard chemotherapy, according to AventisPasteur 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 eliminatecancer cells that may not be eliminated with traditional treatment of metastaticcolorectal cancer using the standard, first-line chemotherapy regimen,"said Dr. Neil Berinstein, assistant vice president, clinical oncology, andprogram director, cancer, Aventis Pasteur. "We will be looking to see ifthe vaccine, combined with chemotherapy, allows a better outcome for patientsthan chemotherapy alone," he added.

Study Design

The multicenter, pilot phase II trial is designed to assesssafety and immunologic activity, and will randomly assign patients to one ofthree treatment groups. One group will be vaccinated with ALVAC-CEA/B7.1 beforebeginning standard chemotherapy (with irinotecan [CPT-11, Camptosar],fluorouracil [5-FU], and leucovorin) and will receive additional, concurrentdoses of the vaccine with the chemotherapy. Another group will receive the sameregimen described above plus doses of tetanus toxoid to determine whether thisadditional compound further enhances the immune response. The third group willreceive standard chemotherapy; patients in this group who achieve complete orpartial responses will have the option of receiving the ALVAC-CEA/B7.1 vaccineupon completion of the chemotherapy.

Treatment will require approximately 28 to 31 weeks, dependingon which group patients are assigned to and how well they tolerate thechemotherapy regimen. Patients will be evaluated routinely for local andsystemic adverse events immediately following treatment and at each follow-upvisit. Immune response and efficacy measures for objective response and responseduration will also be assessed at several predesignated points during treatmentand 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 studylocations and eligibility contact Aventis Pasteur Limited in Toronto at1-866/455-0349.