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

Inclusion Criteria

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