Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030823
Status:
COMPLETED
Last Update Posted:
2015-12-30
First Post:
2002-02-14
Brief Title:
Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Vaccination Of High Risk Breast Cancer Patients With Heptavalent Antigen - Keyhole Limpet Hemocyanin Conjugate Plus The Immunological Adjuvant QS21
Status:
COMPLETED
Status Verified Date:
2015-11
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 and decrease the recurrence of breast cancer
PURPOSE Pilot trial to study the effectiveness of vaccine therapy in treating patients who are at high risk for breast cancer recurrence
PURPOSE Pilot trial to study the effectiveness of vaccine therapy in treating patients who are at high risk for breast cancer recurrence
Detailed Description:
OBJECTIVES
Determine whether immunization with multiple antigens comprising GM2 Globo-H Lewis y TFc sTnc Tnc and glycosylated MUC-1 32aa conjugated to keyhole limpet hemocyanin plus QS21 induces an antibody response against these individual antigens and breast cancer cells expressing these antigens in patients at high risk for breast cancer recurrence
Determine the toxic effects of this regimen in these patients
OUTLINE Patients receive Globo-H-GM2-Lewis-y-MUC1-32aa-sTnc-TFc-Tnc-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1 2 3 7 and 19
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 2-3 months
Determine whether immunization with multiple antigens comprising GM2 Globo-H Lewis y TFc sTnc Tnc and glycosylated MUC-1 32aa conjugated to keyhole limpet hemocyanin plus QS21 induces an antibody response against these individual antigens and breast cancer cells expressing these antigens in patients at high risk for breast cancer recurrence
Determine the toxic effects of this regimen in these patients
OUTLINE Patients receive Globo-H-GM2-Lewis-y-MUC1-32aa-sTnc-TFc-Tnc-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1 2 3 7 and 19
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 2-3 months
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-H01-0084 | None | None | None |
| MSKCC-01019 | None | None | None |