Colorectal Cancer Clinical Trial
Official title:
A Non-Randomized Multicenter Phase I/II Study Of Active Specific Immunotherapy In Patients With Stage II and Stage III Colon Cancer
RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the
body build an immune response to kill tumor cells. Drugs used in chemotherapy use different
ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine
therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy combined with
leucovorin and fluorouracil in treating patients who have undergone surgery to completely
remove stage II or stage III colon cancer.
OBJECTIVES:
- Determine safety and immunogenicity of adjuvant autologous tumor cell vaccine in
patients with completely resected stage II or III adenocarcinoma of the colon.
OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (II
vs III).
Beginning 28-35 days after total surgical resection, patients receive adjuvant autologous
tumor cell vaccine intradermally once weekly for 3 vaccinations. The first 2 vaccinations
also contain BCG. Patients with stage II disease receive a fourth vaccination 6 months after
surgical resection.
Beginning 10-17 days after the third vaccination, patients with stage III disease receive
adjuvant leucovorin calcium IV and fluorouracil IV on days 1-5. Chemotherapy continues every
28-35 days for a total of 6 courses. These patients also receive a fourth vaccination 1
month after the completion of chemotherapy.
Patients are followed at 90 days and 6 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
;
Primary Purpose: Treatment
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