Vaccine Therapy in Treating Patients With Colorectal Cancer Metastatic to the Liver

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sequential Phase II Study of the Anti-Idiotype Monoclonal Antibody Vaccine CeaVac and TriAb in Patients With Minimal Metastatic Colorectal Cancer

Conditions
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Colorectal Cancer, Metastatic Cancer

Intervention / Treatment
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* Biological: monoclonal antibody 11D10 anti-idiotype
* Biological: monoclonal antibody 3H1 Alu Gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined Monoclonal Antibody Therapy<br>Patients with minimal metastatic colorectal cancer are treated with 2 anti-idiotype monoclonal antibodies | Biological: monoclonal antibody 11D10 anti-idiotype<br>* 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<br>* Other names: TriAb;Biological: monoclonal antibody 3H1 Alu Gel<br>* 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<br>* Other names: CeaVac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, liver metastases