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| Sponsored by: |
Centro Oncologico de Excelencia |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002455 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer Colorectal Cancer Melanoma (Skin) |
Biological: Corynebacterium granulosum P40 Procedure: adjuvant therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Immunotherapy of Colon Cancer With Autologous Perchloric Soluble Tumors Extracts |
| Study Start Date: | April 1971 |
OBJECTIVES:
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
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| Argentina, Buenos Aires | |
| Centro Oncologico de Excelencia | |
| Gonnet, Buenos Aires, Argentina, 1987 MB | |
| Study Chair: | Hugo Omar De Carli, MD | Centro Oncologico de Excelencia |
More Information
| Study ID Numbers: | CDR0000072435, ARG-CO/BR-1 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002455 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Digestive System Neoplasms Skin Diseases Gastrointestinal Diseases Colonic Diseases Adjuvants, Immunologic Breast Neoplasms Intestinal Diseases Rectal Diseases Recurrence Intestinal Neoplasms Neuroendocrine Tumors |
Melanoma Neuroectodermal Tumors Digestive System Diseases Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Gastrointestinal Neoplasms Nevus Colonic Neoplasms Colorectal Neoplasms Breast Diseases |
|
Neoplasms by Histologic Type Digestive System Neoplasms Skin Diseases Gastrointestinal Diseases Neoplasms, Nerve Tissue Colonic Diseases Breast Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Neuroendocrine Tumors |
Melanoma Neuroectodermal Tumors Neoplasms Neoplasms by Site Digestive System Diseases Neoplasms, Germ Cell and Embryonal Gastrointestinal Neoplasms Nevi and Melanomas Colonic Neoplasms Colorectal Neoplasms Breast Diseases |
