Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004156
Status:
COMPLETED
Last Update Posted:
2013-10-30
First Post:
1999-12-10
Brief Title:
Vaccine Therapy in Treating Patients With Breast Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Vaccination of High Risk Breast Cancer Patients With MUC-1 Glycosylated Keyhole Limpet Hemocyanin Conjugates Plus the Immunological Adjuvant QS21
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
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 Vaccines may make the body build an immune response to kill tumor cells
Detailed Description:
OBJECTIVES I Determine if immunization with glycosylated MUC-1 antigen containing MUC-1106 or MUC-133 with keyhole limpet hemocyanin conjugate plus immunological adjuvant QS21 induces an antibody helper T cell andor cytotoxic T cell response against MUC-1 in patients with high risk breast cancer expressing MUC-1
OUTLINE Patients receive glycosylated MUC-1 antigen containing MUC-1106 or MUC-133 with keyhole limpet hemocyanin conjugate subcutaneously SQ plus immunological adjuvant QS21 SQ on weeks 1-3 7 and 19 for a total of 5 vaccinations Patients are followed every 3 months
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study
OUTLINE Patients receive glycosylated MUC-1 antigen containing MUC-1106 or MUC-133 with keyhole limpet hemocyanin conjugate subcutaneously SQ plus immunological adjuvant QS21 SQ on weeks 1-3 7 and 19 for a total of 5 vaccinations Patients are followed every 3 months
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-H99-0043 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067394 | REGISTRY | None | None |