Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292045
Status:
COMPLETED
Last Update Posted:
2023-10-04
First Post:
2006-02-13
Brief Title:
Immunization With NY-ESO-1 Protein Combined With CpG 7909 in Patients With Prostate Cancer
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
Phase 1 Study of Immunization With NY-ESO-1 Protein Combined With CpG 7909 in Patients With High-risk Stage D1 or Advanced Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2023-10
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:
This was a Phase 1 open-label fixed-dose study of immunization with the NY-ESO-1 protein combined with CpG 7909 as an adjuvant in patients with histopathologically confirmed high-risk Stage D1 or advanced prostate cancer The primary study objective was to assess the safety of NY-ESO-1 proteinCpG 7909 immunization and the secondary objective was to evaluate the immunity induced by immunization
Detailed Description:
Eligible patients received vaccinations consisting of the NY-ESO-1 protein 100 µg combined with CpG 7909 25 mg administered intradermally every 3 weeks for 4 doses Patients who demonstrated stable disease minor response partial response or complete response at Week 13 may have continued to receive vaccinations until disease progression In patients with mixed response single progressive lesions may have been resected and vaccination may have been continued
Safety was monitored continuously Blood samples were obtained for clinical hematology biochemistry and immune response assessments including antinuclear antibody ANA and anti-dsDNA NY-ESO-1 andor LAGE-1 specific antibodies and NY-ESO-1 specific cluster of differentiation CD4 and CD8 T cells
A tumor sample resected prior to immunization was tested to determine NY-ESO-1 andor LAGE-1 expression Delayed-type hypersensitivity DTH testing was performed at baseline and on study
Disease status was assessed at baseline and on study in patients with measurable disease
Safety was monitored continuously Blood samples were obtained for clinical hematology biochemistry and immune response assessments including antinuclear antibody ANA and anti-dsDNA NY-ESO-1 andor LAGE-1 specific antibodies and NY-ESO-1 specific cluster of differentiation CD4 and CD8 T cells
A tumor sample resected prior to immunization was tested to determine NY-ESO-1 andor LAGE-1 expression Delayed-type hypersensitivity DTH testing was performed at baseline and on study
Disease status was assessed at baseline and on study in patients with measurable disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| KEK-StV-Nr 0104 local EC | None | None | None |
| 2004DR1380 SwissMedic | None | None | None |