Vaccine Therapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
Colorectal Cancer, Metastatic Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, liver metastases
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
Sites / Locations
- Northeast Alabama Regional Medical Center
- Rebecca and John Moores UCSD Cancer Center
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
- Naval Medical Center - San Diego
- Veterans Affairs Medical Center - San Diego
- UCSF Comprehensive Cancer Center
- Veterans Affairs Medical Center - San Francisco
- CCOP - Christiana Care Health Services
- Lombardi Cancer Center at Georgetown University Medical Center
- Walter Reed Army Medical Center
- Veterans Affairs Medical Center - Washington, DC
- Broward General Medical Center
- Memorial Regional Cancer Center at Memorial Regional Hospital
- CCOP - Mount Sinai Medical Center
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- CCOP - Illinois Oncology Research Association
- West Suburban Center for Cancer Care
- Fort Wayne Medical Oncology and Hematology, Incorporated
- CCOP - Northern Indiana CR Consortium
- Hematology Oncology Associates of the Quad Cities
- Holden Comprehensive Cancer Center at University of Iowa
- Baptist Hospital East - Louisville
- Greenebaum Cancer Center at University of Maryland Medical Center
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- University of Massachusetts Memorial Medical Center - University Campus
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
- Veterans Affairs Medical Center - Minneapolis
- University of Minnesota Cancer Center
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- CCOP - Kansas City
- Siteman Cancer Center
- Missouri Baptist Cancer Center
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- CCOP - Southern Nevada Cancer Research Foundation
- Veterans Affairs Medical Center - Las Vegas
- New Hampshire Oncology-Hematology, PA - Hooksett
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Cooper University Hospital
- Veterans Affairs Medical Center - Buffalo
- Roswell Park Cancer Institute
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- Elmhurst Hospital Center
- Queens Cancer Center of Queens Hospital
- CCOP - North Shore University Hospital
- North Shore University Hospital
- Memorial Sloan-Kettering Cancer Center
- New York Weill Cornell Cancer Center at Cornell University
- Mount Sinai Medical Center
- University Hospital at State University of New York - Upstate Medical University
- Veterans Affairs Medical Center - Syracuse
- Veterans Affairs Medical Center - Asheville
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- NorthEast Oncology Associates - Concord
- Veterans Affairs Medical Center - Durham
- Duke Comprehensive Cancer Center
- Cape Fear Valley Health System
- CCOP - Southeast Cancer Control Consortium
- Lenoir Memorial Hospital Cancer Center
- FirstHealth Moore Regional Hospital
- Zimmer Cancer Center at New Hanover Regional Medical Center
- Comprehensive Cancer Center at Wake Forest University
- Arthur G. James Cancer Hospital at Ohio State University
- Oklahoma University Medical Center
- Western Pennsylvania Hospital
- Lifespan: The Miriam Hospital
- Veterans Affairs Medical Center - Dallas
- Vermont Cancer Center at University of Vermont
- Martha Jefferson Hospital
- Virginia Oncology Associates - Norfolk
- MBCCOP - Massey Cancer Center
- Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
- St. Mary's Medical Center
Arms of the Study
Arm 1
Experimental
Combined Monoclonal Antibody Therapy
Patients with minimal metastatic colorectal cancer are treated with 2 anti-idiotype monoclonal antibodies