Vaccine Therapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
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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 2 |
| 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 |
- Recurrence free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
| 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
|
Detailed Description:
OBJECTIVES:
Primary
- Determine the 2-year recurrence-free survival of patients with minimal metastatic colorectal cancer after hepatic resection when treated with adjuvant monoclonal antibody 3H1 anti-idiotype vaccine and monoclonal antibody 11D10 anti-idiotype vaccine.
Secondary
- Determine the toxicity of this regimen in these patients.
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:
- Histologically confirmed hepatic colorectal metastases
- Must have undergone complete resection of hepatic colorectal metastases with tumor-free margins (curative resection) at least 6, but no more than 10, weeks prior to study entry
- No evaluable or measurable disease after hepatic resection, documented by intraoperative palpation or imaging studies including intraoperative ultrasound, CT scan, or MRI
- No hereditary non-polyposis colon cancer type B
- No CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- CTC 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 4,000/mm^3
- Platelet count at least 150,000/mm^3
Hepatic:
- Bilirubin no greater than 2 mg/dL
- AST no greater than 2 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than 1.5 times ULN
Gastrointestinal:
- No celiac disease
- No familial polyposis
- No Gardner's syndrome
- No Peutz-Jeghers syndrome
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No seizure disorders requiring continuous medication
- No history of clinically significant hypersensitivity reactions, including known hypersensitivity to rodent proteins
- No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior murine antibodies (e.g., oncoscint scan)
- No prior monoclonal antibody 3H1 anti-idiotype vaccine or monoclonal antibody 11D10 anti-idiotype vaccine
Chemotherapy:
- No concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy except steroids for adrenal failure or hormones for non-disease-related conditions (e.g., insulin for diabetes)
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Other:
- Prior treatment for primary lesion or hepatic metastases allowed
- No concurrent immunomodulatory therapy
Contacts and Locations
Show 75 Study Locations| Study Chair: | Mitchell C. Posner, MD | University of Chicago |
More Information
Additional Information:
Publications:
| 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 |
Keywords provided by Cancer and Leukemia Group B:
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer liver metastases |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 22, 2013