Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003002
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
1999-11-01
Brief Title:
HER-2Neu Vaccine Plus GM-CSF in Treating Patients With Stage III or Stage IV Breast Ovarian or Non-small Cell Lung Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Phase I Study of a HER-2Neu Peptide Based Vaccine With GM-CSF as an Adjuvant in Patients With Advanced Stage HER-2Neu Expressing Cancers
Status:
COMPLETED
Status Verified Date:
2019-02
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 the HER2neu antigen may make the body build an immune response and kill tumor cells Colony-stimulating factors such as GM-CSF increase the number of immune cells found in bone marrow or peripheral blood
PURPOSE Phase I trial to study the effectiveness of HER-2neu vaccine plus GM-CSF in treating patients who have stage III or stage IV breast cancer stage III or stage IV ovarian cancer or stage III or stage IV non-small cell lung cancer
PURPOSE Phase I trial to study the effectiveness of HER-2neu vaccine plus GM-CSF in treating patients who have stage III or stage IV breast cancer stage III or stage IV ovarian cancer or stage III or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the safety of serial intradermal vaccinations of HER-2neu derived peptides with sargramostim GM-CSF as an adjuvant in patients with stage III or IV HER-2neu expressing breast ovarian or nonsmall cell lung cancer II Determine whether immunity can be elicited with peptides derived from the intracellular domain of the HER-2neu protein III Determine whether immunity can be elicited with peptides derived from the extracellular domain of the HER-2neu protein IV Determine whether cytotoxic T cells specific for the HER-2neu protein can be elicited in patients with HLA-A2 by immunization with peptides derived from the HER-2neu protein
OUTLINE Patients receive one of three HER-2neu peptide vaccine formulations that also contain sargramostim GM-CSF as the vaccine adjuvant Each vaccine is studied in 20 patients A maximum of 3 patients receive a vaccine each month for 6 months to monitor the potential toxicity associated with sequential immunizations Patients receive a follow-up evaluation 1 month after the last vaccination Those patients who have an immune response related to the vaccine will continue to have immunologic evaluations performed every 2 months while immune responses can still be detected
PROJECTED ACCRUAL 60 patients will be accrued
OUTLINE Patients receive one of three HER-2neu peptide vaccine formulations that also contain sargramostim GM-CSF as the vaccine adjuvant Each vaccine is studied in 20 patients A maximum of 3 patients receive a vaccine each month for 6 months to monitor the potential toxicity associated with sequential immunizations Patients receive a follow-up evaluation 1 month after the last vaccination Those patients who have an immune response related to the vaccine will continue to have immunologic evaluations performed every 2 months while immune responses can still be detected
PROJECTED ACCRUAL 60 patients will be accrued
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-V97-1259 | None | None | None |
| UW-1001 | None | None | None |