A Non-Randomized Multicenter Phase I/II Study Of Active Specific Immunotherapy In Patients With Stage II and Stage III Colon Cancer

Inclusion 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