Vaccine Therapy in Treating Patients With Stage IIB, Stage III, or Stage IV Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage IIB colon cancer, stage IIIA colon cancer, stage IIIB colon cancer, stage IIIC colon cancer, stage IVA colon cancer, stage IVB colon cancer, recurrent rectal cancer, stage IIB rectal cancer, stage IIIA rectal cancer, stage IIIB rectal cancer, stage IIIC rectal cancer, stage IVA rectal cancer, stage IVB rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of colorectal cancer Stage IIB, III, or IV disease HLA-A2- or -A3-positive PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count > 1,000/mm^3 Hemoglobin > 9 g/dL Platelet count > 100,000/mm^3 Hepatic Liver function tests ≤ 2.5 times upper limit of normal (ULN) Renal Creatinine ≤ 1.5 times ULN Cardiovascular No New York Heart Association class III or IV heart disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known or suspected allergies to any component of the study drug No active connective tissue disease requiring medications No systemic autoimmune disease with visceral involvement No uncontrolled diabetes No other severe autoimmune disease No medical contraindication or potential problem that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy More than 30 days since prior immunotherapy More than 30 days since prior growth factors More than 30 days since prior allergy shots No prior vaccination with any study peptides for malignancy Chemotherapy More than 30 days since prior chemotherapy Endocrine therapy More than 30 days since prior steroids Radiotherapy More than 30 days since prior radiotherapy Surgery More than 30 days since prior surgery Other At least 30 days, but ≤ 24 months, since prior therapy for colorectal cancer No concurrent illegal drug use
Sites / Locations
- University of Virginia Cancer Center
Arms of the Study
Arm 1
Experimental
Peptide Vaccine + Montanide + GM-CSF
Colon peptide mixture (100 mcg each of the 4 peptides) plus 190 mcg of tetanus toxoid peptide, plus GM-CSF (110 mcg) in Montanide ISA-51 adjuvant