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| Sponsors and Collaborators: |
Herbert Irving Comprehensive Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00027833 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Biological: ALVAC-CEA-B7.1 vaccine Biological: tetanus toxoid Drug: FOLFIRI regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control |
| Official Title: | 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 |
| Study Start Date: | December 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 3 treatment arms.
PROJECTED ACCRUAL: A total of 90 patients (30 per treatment arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Gastrointestinal:
Immunologic:
No diagnosis of altered immune function, including:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35243 | |
| United States, California | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| United States, District of Columbia | |
| Lombardi Cancer Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, New York | |
| Herbert Irving Comprehensive Cancer Center | |
| New York, New York, United States, 10032 | |
| United States, Oregon | |
| Earle A. Chiles Research Institute at Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213-2967 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Scranton Hematology-Oncology | |
| Scranton, Pennsylvania, United States, 18510 | |
| Canada, Ontario | |
| Ottawa Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| McGill University | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Study Chair: | Howard L. Kaufman, MD | Herbert Irving Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000069082, CPMC-14534, CPMC-BB-IND-9911, FCCC-01015, APL-COL13, NCI-G01-2033 |
| Study First Received: | December 7, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00027833 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV colon cancer stage IV rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
|
Antimetabolites Immunologic Factors Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Irinotecan Leucovorin Tetanus Rectal Diseases Vitamins Micronutrients Vitamin B Complex Digestive System Neoplasms Rectal Neoplasm Trace Elements |
Folinic Acid Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Camptothecin Carcinoma Calcium, Dietary Digestive System Diseases Rectal Cancer Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Antineoplastic Agents, Phytogenic Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Physiological Effects of Drugs Colonic Diseases Irinotecan Leucovorin Rectal Diseases Neoplasms by Site Vitamins Therapeutic Uses Micronutrients |
Vitamin B Complex Digestive System Neoplasms Neoplasms by Histologic Type Growth Substances Enzyme Inhibitors Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Camptothecin Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms |