Immunotherapy After Surgery in Treating Patients With Breast Cancer, Colon Cancer, or Melanoma
- Conditions
- Breast CancerColorectal CancerMelanoma (Skin)
- Registration Number
- NCT00002455
- Lead Sponsor
- Centro Oncologico de Excelencia
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence Response to study parameters Survival rate
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centro Oncologico de Excelencia
🇦🇷Gonnet, Buenos Aires, Argentina