Immunotherapy After Surgery in Treating Patients With Breast Cancer, Colon Cancer, or Melanoma

Study Overview
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Brief Summary
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RATIONALE: Immunotherapy uses different ways to stimulate the immune system and stop cancer cells from growing. Immunotherapy biological extracts may be useful as adjuvant therapy in treating patients who have had surgery for breast cancer, colon cancer, or melanoma. PURPOSE: Phase III trial to study the effectiveness of Corynebacterium granulosum extract as maintenance immunotherapy following surgery in treating patients with breast cancer, colon cancer, or melanoma.

Detailed Description
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OBJECTIVES: Determine the survival of patients with colon cancer, breast cancer, or melanoma with minimal residual disease after surgical resection treated with maintenance immunotherapy using Corynebacterium granulosum P40. Determine leucocyte adherence inhibition, an indication of metastases, over time in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified by center and are matched with case-controls by disease type and stage. Beginning 2 weeks after surgical resection, patients receive Corynebacterium granulosum P40 subcutaneously weekly for 6 weeks, followed by rest for 3 months. Treatment continues for life. Patients are followed for survival. PROJECTED ACCRUAL: Not specified

Official Title
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Immunotherapy of Colon Cancer With Autologous Perchloric Soluble Tumors Extracts

Conditions
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Breast Cancer, Colorectal Cancer, Melanoma (Skin)

Intervention / Treatment
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* Biological: Corynebacterium granulosum P40
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of colon cancer, breast cancer, or melanoma with minimal residual disease (at least 90% of tumor mass resected) after surgical resection Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 20 to 80 Sex: Not specified Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Corynebacterium granulosum P40|nan|
|Procedure: adjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence |  |  | 
| Response to study parameters |  |  | 
| Survival rate |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I colon cancer, stage II colon cancer, stage III colon cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, recurrent breast cancer, recurrent colon cancer, stage I melanoma, stage II melanoma, stage III melanoma, recurrent melanoma