Pilot Phase II Study of Safety and Immunogenicity of an ALVAC-CEA/B7.1 Vaccine Administered With Chemotherapy, Alone or in Combination With Tetanus Toxoid, as Compared to Chemotherapy Alone, in Patients With Metastatic Colorectal Adenocarcinoma
- Determine the safety of ALVAC-CEA-B7.1 vaccine and chemotherapy, with or without
tetanus toxoid, vs chemotherapy alone in patients with metastatic colorectal
- Determine whether tetanus toxoid enhances the immune response in patients treated with
the vaccine and chemotherapy.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1
of 3 treatment arms.
- Arm I: Patients receive a priming dose of tetanus toxoid. Beginning 2 weeks later,
patients receive tetanus toxoid and ALVAC-CEA-B7.1 vaccine subcutaneously (SC) once
weekly for 3 weeks.
Two weeks after the third vaccine administration, patients receive tetanus toxoid and
ALVAC-CEA-B7.1 vaccine SC on day 1 and irinotecan IV over 90 minutes, leucovorin calcium IV,
and fluorouracil IV on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for 4 courses
in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive ALVAC-CEA-B7.1 vaccine and chemotherapy as in arm I.
- Arm III: Patients receive chemotherapy as in arm I. After completion of chemotherapy,
patients with partial or complete response may receive ALVAC-CEA-B7.1 vaccine SC once
weekly on weeks 1-3 and 6.
PROJECTED ACCRUAL: A total of 90 patients (30 per treatment arm) will be accrued for this
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Howard L. Kaufman, MD
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University||Chicago, Illinois 60611|
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|
|Lombardi Cancer Center||Washington, District of Columbia 20007|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Herbert Irving Comprehensive Cancer Center||New York, New York 10032|
|Earle A. Chiles Research Institute at Providence Portland Medical Center||Portland, Oregon 97213-2967|
|Scranton Hematology-Oncology||Scranton, Pennsylvania 18510|