Vaccine Therapy in Treating Patients With Stage II or Stage III Colon Cancer That Has Been Removed During Surgery
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage II colon cancer, stage III colon cancer, adenocarcinoma of the colon
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage II or III primary adenocarcinoma of the colon Completely resected within the past 28-35 days, at which time tumor tissue is harvested for vaccine production No residual or metastatic disease No more than 1 malignant invasive primary colon cancer No tumor originating in the rectum (i.e., inferior tumor margin must not be at or below the peritoneal reflection) No perforated tumors PATIENT CHARACTERISTICS: Age: 21 to 85 Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 10.0 g/dL Hepatic: Bilirubin normal SGOT normal Alkaline phosphatase normal No severe hepatic disease that would preclude study Renal: Creatinine less than 1.5 times upper limit of normal No severe renal disease that would preclude study Cardiovascular: No prosthetic cardiac valves No recent vascular prosthesis No postsurgical cardiovascular complication No severe cardiovascular disease that would preclude study Pulmonary: No postsurgical pulmonary complication Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No insulin-dependent diabetes mellitus No severe systemic disease that would preclude study No congenital or acquired immune deficiency disease No history of chronic ulcerative colitis, Crohn's disease, Gardner's syndrome, or Turcot's syndrome No ileus No other prior malignancy except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix No ongoing infection requiring systemic antibiotics No severe postoperative complication that would preclude study Carcinoembryonic antigen normal PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent investigational immunotherapy Chemotherapy: No prior systemic chemotherapy No other concurrent investigational chemotherapy Endocrine therapy: No concurrent steroids Radiotherapy: No prior radiotherapy No concurrent investigational radiotherapy Surgery: See Disease Characteristics No concurrent investigational surgery Other: At least 3 weeks since prior systemic antibiotic therapy of more than 5 days duration (excluding topical antibiotics or perioperative prophylactic antibiotics) No concurrent cytotoxic immunosuppressive agents
Sites / Locations
- John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
- Inova Fairfax Hospital