Vaccine Therapy in Treating Patients With Stage II or Stage III Colon Cancer That Has Been Removed During Surgery

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.

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