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| Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00033748 |
Purpose
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 |
|---|---|---|
|
Colorectal Cancer Metastatic Cancer |
Biological: monoclonal antibody 11D10 anti-idiotype vaccine Biological: 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.
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:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 75 Study Locations| Study Chair: | Mitchell C. Posner, MD | University of Chicago |
More Information
| Study ID Numbers: | CDR0000069324, CALGB-89903 |
| Study First Received: | April 9, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00033748 History of Changes |
| 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 Immunologic Factors Immunoglobulin Idiotypes Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Adjuvants, Immunologic Rectal Neoplasm Intestinal Diseases Rectal Diseases |
Recurrence Intestinal Neoplasms Antibodies, Monoclonal Antibodies Digestive System Diseases Rectal Cancer Neoplasm Metastasis Gastrointestinal Neoplasms Colorectal Neoplasms Immunoglobulins |
|
Digestive System Neoplasms Immunologic Factors Immunoglobulin Idiotypes Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Intestinal Diseases Rectal Diseases Pharmacologic Actions Intestinal Neoplasms Antibodies, Monoclonal |
Antibodies Neoplasms Neoplastic Processes Pathologic Processes Neoplasms by Site Digestive System Diseases Neoplasm Metastasis Gastrointestinal Neoplasms Colorectal Neoplasms Immunoglobulins |