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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Cancer and Leukemia Group B |
| 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 Neoplasm Metastasis |
Biological: monoclonal antibody 11D10 anti-idiotype Biological: monoclonal antibody 3H1 Alu Gel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Sequential Phase II Study of the Anti-Idiotype Monoclonal Antibody Vaccine CeaVac and TriAb in Patients With Minimal Metastatic Colorectal Cancer |
| Enrollment: | 56 |
| Study Start Date: | December 2001 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Combined Monoclonal Antibody Therapy
Patients with minimal metastatic colorectal cancer are treated with 2 anti-idiotype monoclonal antibodies
|
Biological: monoclonal antibody 11D10 anti-idiotype
2 mg intradermal injection q 14 days for 4 doses, then sub Q monthly for 4 months, following a 6-12 wk rest period after curative hepatic resection
Other Name: TriAb
Biological: monoclonal antibody 3H1 Alu Gel
2 mg intradermal injection q 14 days for 4 doses, then sub Q monthly for 4 months, following a 6-12 wk rest period after curative hepatic resection
Other Name: CeaVac
|
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
| Responsible Party: | Monica M Bertagnolli, MD, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00033748 History of Changes |
| Other Study ID Numbers: | CDR0000069324, U10CA031946, CALGB-89903 |
| Study First Received: | April 9, 2002 |
| Last Updated: | April 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer liver metastases |
|
Neoplasms Colorectal Neoplasms Neoplasm Metastasis Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Neoplastic Processes Pathologic Processes Antibodies Immunoglobulins Antibodies, Monoclonal Immunoglobulin Idiotypes Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |