Viewing Study NCT00004156



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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

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