Colorectal Cancer, Metastatic Cancer
Conditions
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, liver metastases
Brief 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.
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.
Interventions
BIOLOGICALmonoclonal 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
BIOLOGICALmonoclonal 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
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence free survival | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity | 5 years |
Countries
United States
Outcome results
None listed