Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00470574
Status:
COMPLETED
Last Update Posted:
2020-11-18
First Post:
2007-05-03
Brief Title:
Vaccine Therapy and QS21 in Treating Patients With Metastatic Breast Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Pilot Study of Immunization of High Risk Breast Cancer Patients With a Sialyl Lewisª -Keyhole Limpet Hemocyanin Conjugate Plus the Immunological Adjuvant QS-21
Status:
COMPLETED
Status Verified Date:
2020-11
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 help the body build an effective immune response to kill tumor cells Giving vaccine therapy together with QS21 may cause a stronger immune response and kill more tumor cells
PURPOSE This clinical trial is studying the side effects and how well giving vaccine therapy together with QS21 works in treating patients with metastatic breast cancer
PURPOSE This clinical trial is studying the side effects and how well giving vaccine therapy together with QS21 works in treating patients with metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety of sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine and QS21 immunoadjuvant in patients with metastatic breast cancer
Determine the IgG and IgM antibody response to this regimen in these patients
Determine the proportion of breast cancer cells expressing this antigen in these patients
Secondary
Monitor the presence of circulating tumor cells prior to during and after this regimen in these patients
OUTLINE Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously SC and QS21 immunoadjuvant SC once in weeks 1 2 3 7 and 19 in the absence of disease progression or unacceptable disease
Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA andor immunoprecipitation-western blot assays
After completion of study treatment patients are followed every 3 months
Primary
Determine the safety of sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine and QS21 immunoadjuvant in patients with metastatic breast cancer
Determine the IgG and IgM antibody response to this regimen in these patients
Determine the proportion of breast cancer cells expressing this antigen in these patients
Secondary
Monitor the presence of circulating tumor cells prior to during and after this regimen in these patients
OUTLINE Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously SC and QS21 immunoadjuvant SC once in weeks 1 2 3 7 and 19 in the absence of disease progression or unacceptable disease
Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA andor immunoprecipitation-western blot assays
After completion of study treatment patients are followed every 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 |
|---|---|---|---|
| MSKCC-06156 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |