Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002455
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
1999-11-01
Brief Title:
Immunotherapy After Surgery in Treating Patients With Breast Cancer Colon Cancer or Melanoma
Sponsor:
Centro Oncologico de Excelencia
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Immunotherapy of Colon Cancer With Autologous Perchloric Soluble Tumors Extracts
Status:
UNKNOWN
Status Verified Date:
1998-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000072435 | REGISTRY | PDQ Physician Data Query | None |