Colon Cancer Clinical Trial
Vaccine Therapy in Treating Patients With Stage II or Stage III Colon Cancer That Has Been Removed During Surgery
Summary
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.
Full Description
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.
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
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There are 2 Locations for this study
Allentown Pennsylvania, 18105, United States
Fairfax Virginia, 22031, United States
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