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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00033748 |
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have colorectal cancer that has spread to the liver.
Condition | Intervention | Phase |
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Colorectal Cancer Metastatic Cancer |
Drug: monoclonal antibody 11D10 anti-idiotype vaccine Drug: monoclonal antibody 3H1 anti-idiotype vaccine Procedure: adjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Sequential Phase II Study of the Anti-Idiotype Monoclonal Antibody Vaccine CeaVac and TriAb in Patients With Minimal Metastatic Colorectal Cancer |
Study Start Date: | December 2001 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Beginning 6-12 weeks after curative hepatic resection, patients receive monoclonal antibody 3H1 anti-idiotype vaccine and monoclonal antibody 11D10 anti-idiotype vaccine intracutaneously at separate sites on days 1, 15, 29, and 45, then subcutaneously monthly for 4 months.
PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study within 9 months.
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:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Mitchell C. Posner, MD | University of Chicago |
Study ID Numbers: | CDR0000069324, CALGB-89903 |
Study First Received: | April 9, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00033748 |
Health Authority: | United States: Federal Government |
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer liver metastases |
Digestive System Neoplasms Immunoglobulin Idiotypes Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Recurrence Intestinal Neoplasms |
Rectal neoplasm Antibodies, Monoclonal Antibodies Digestive System Diseases Neoplasm Metastasis Gastrointestinal Neoplasms Rectal cancer Colorectal Neoplasms Immunoglobulins |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |