Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068614
Status:
COMPLETED
Last Update Posted:
2014-02-05
First Post:
2003-09-10
Brief Title:
HER-2 Protein Vaccine in Treating Women With Breast Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Phase I Trial Evaluating The Safety Of Intramuscular Injections Of HER-2 Protein AUTOVAC PX10416 In Patients With Breast Cancer
Status:
COMPLETED
Status Verified Date:
2014-02
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 may make the body build an immune response to kill tumor cells
PURPOSE Phase I trial to study the effectiveness of HER-2 protein vaccine in treating women who have breast cancer
PURPOSE Phase I trial to study the effectiveness of HER-2 protein vaccine in treating women who have breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety of HER-2 protein AutoVac in women with breast cancer
Secondary
Determine the ability of this drug to bypass the tolerance to the HER-2 self-protein by raising HER-2 antibodies in these patients
Determine the kinetics of the immune response to HER-2neu in patients treated with this drug
OUTLINE This is an open-label multicenter study
Patients receive HER-2 protein AutoVac intramuscularly at weeks 0 2 6 and 10 in the absence of unacceptable toxicity
Patients are followed for up to 6 weeks
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study within 3 months
Primary
Determine the safety of HER-2 protein AutoVac in women with breast cancer
Secondary
Determine the ability of this drug to bypass the tolerance to the HER-2 self-protein by raising HER-2 antibodies in these patients
Determine the kinetics of the immune response to HER-2neu in patients treated with this drug
OUTLINE This is an open-label multicenter study
Patients receive HER-2 protein AutoVac intramuscularly at weeks 0 2 6 and 10 in the absence of unacceptable toxicity
Patients are followed for up to 6 weeks
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study within 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 |
|---|---|---|---|
| PHARMEXA-PX10416-101 | Registry Identifier | PDQ Physician Data Query | None |
| CWRU-030339 | None | None | None |
| CDR0000327784 | REGISTRY | None | None |