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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Biological: BCG vaccine
* Biological: autologous tumor cell vaccine
* Drug: fluorouracil
* Drug: leucovorin calcium
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: BCG vaccine|nan|
|Biological: autologous tumor cell vaccine|nan|
|Drug: fluorouracil|nan|
|Drug: leucovorin calcium|nan|
|Procedure: adjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III colon cancer, stage II colon cancer, adenocarcinoma of the colon