vaccine therapy in treating patients with colorectal cancer metastatic to the liver

Conditions: Colorectal Cancer; Metastatic Cancer

Summary: 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.

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 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

Keywords: stage iv colon cancer stage iv rectal cancer recurrent colon cancer recurrent rectal cancer liver metastases