Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00027833
- Lead Sponsor
- Herbert Irving Comprehensive Cancer Center
- Brief Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Tetanus toxoid may make tumor cells more sensitive to chemotherapy and vaccine therapy.
PURPOSE: Randomized phase II trial to study the effectiveness of chemotherapy and vaccine therapy with or without tetanus toxoid compared with chemotherapy alone in treating patients who have metastatic colorectal cancer.
- Detailed Description
OBJECTIVES:
* Determine the safety of ALVAC-CEA-B7.1 vaccine and chemotherapy, with or without tetanus toxoid, vs chemotherapy alone in patients with metastatic colorectal adenocarcinoma.
* 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 study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Scranton Hematology-Oncology
🇺🇸Scranton, Pennsylvania, United States
McGill University
🇨🇦Montreal, Quebec, Canada
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
Earle A. Chiles Research Institute at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States