Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003357
Status:
COMPLETED
Last Update Posted:
2012-12-13
First Post:
1999-11-01
Brief Title:
Vaccine Therapy Plus QS21 in Treating Women With Breast Cancer Who Have No Evidence of Disease
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Vaccination of High Risk Breast Cancer Patients Lacking Identifiable Disease With GM2-KLH Conjugate Plus the Immunological Adjuvant QS21
Status:
COMPLETED
Status Verified Date:
2012-12
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 made from GM2-KLH and given with QS21 may make the body build an immune response to and kill tumor cells
PURPOSE Phase I trial to study the effectiveness of GM2-KLH vaccine plus QS21 in treating patients with breast cancer who have no evidence of disease
PURPOSE Phase I trial to study the effectiveness of GM2-KLH vaccine plus QS21 in treating patients with breast cancer who have no evidence of disease
Detailed Description:
OBJECTIVES I Determine whether immunization with GM2-KLH vaccine plus the immunological adjuvant QS21 induces an antibody response against GM2 and cells expressing GM2 in disease free patients at high risk for recurrence of breast cancer
OUTLINE GM2-KLH vaccine plus QS21 is administered subcutaneously to sites on the upper arm and upper leg at weekly intervals for 4 weeks Two additional vaccines are administered at weeks 12 and 24 Patients are followed every 3 months after the sixth vaccination
PROJECTED ACCRUAL A total of 9 patients will be accrued for this study within 1 year
OUTLINE GM2-KLH vaccine plus QS21 is administered subcutaneously to sites on the upper arm and upper leg at weekly intervals for 4 weeks Two additional vaccines are administered at weeks 12 and 24 Patients are followed every 3 months after the sixth vaccination
PROJECTED ACCRUAL A total of 9 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| MSKCC-97123 | None | None | None |
| NCI-H98-0015 | None | None | None |