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.

Condition	Treatment or Intervention	Phase
Breast Cancer Colon Cancer Melanoma	Drug: Corynebacterium granulosum P40  Procedure: adjuvant therapy  Procedure: biological response modifier therapy  Procedure: non-specific immune-modulator therapy	Phase III

Further Study Details: 

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

Ages Eligible for Study:  20 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

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

Argentina, Buenos Aires
      Centro Oncologico de Excelencia, Gonnet,  Buenos Aires,  1987 MB,  Argentina; Recruiting

Study chairs or principal investigators

Hugo Omar De Carli, MD,  Study Chair,  Centro Oncologico de Excelencia   

Study ID Numbers:  CDR0000072435; ARG-CO/BR-1; NCT00002455
Record last reviewed:  May 2001
Last Updated:  December 3, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002455
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08