Immunotherapy of Colon Cancer With Autologous Perchloric Soluble Tumors Extracts
20 Years
80 Years
Both
Breast Cancer, Colorectal Cancer, Melanoma (Skin)
Trial Information
Immunotherapy of Colon Cancer With Autologous Perchloric Soluble Tumors Extracts
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
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Recurrence
Safety Issue:
No
Principal Investigator
Hugo Omar De Carli, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centro Oncologico de Excelencia
Authority:
United States: Federal Government
Study ID:
CDR0000072435
NCT ID:
NCT00002455
Start Date:
April 1971
Completion Date:
Related Keywords:
- Breast Cancer
- Colorectal Cancer
- Melanoma (Skin)
- 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
- Breast Neoplasms
- Colonic Neoplasms
- Colorectal Neoplasms
- Melanoma
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