Ignite Creation Date:
2024-05-06 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03020017
Status:
COMPLETED
Last Update Posted:
2022-08-26
First Post:
2017-01-11
Brief Title:
NU-0129 in Treating Patients With Recurrent Glioblastoma or Gliosarcoma Undergoing Surgery
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase 0 First-In-Human Study Using NU-0129 A Spherical Nucleic Acid SNA Gold Nanoparticle Targeting BCL2L12 in Recurrent Glioblastoma Multiforme or Gliosarcoma Patients
Status:
COMPLETED
Status Verified Date:
2022-08
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:
The purpose of this research study is to evaluate the safety of the study drug NU-0129 based on Spherical Nucleic Acid SNA platform when infused in patients with recurrent glioblastoma multiforme or gliosarcoma The SNA consists of nucleic acids arranged on the surface of a small spherical gold nanoparticle This is a first-in-human trial to determine the safety of NU-0129 NU-0129 can cross the blood brain barrier a filtering mechanism that carry blood to the brain Once within the tumor the nucleic acid component is able to target a gene called Bcl2L12 that is present in glioblastoma multiforme and is associated with tumor growth This gene prevents tumor cells from apoptosis which is the process of programmed cell death thus promoting tumor growth Researchers think that targeting the Bcl2L12 gene with NU-0129 will help stop cancer cells from growing
Detailed Description:
PRIMARY OBJECTIVES
I To assess the safety of intravenous NU-0129 in patients with recurrent glioblastoma multiforme GBM or gliosarcoma GS
SECONDARY OBJECTIVES
I To analyze drug concentration in serum at specific time points after drug administration
II To demonstrate intratumoral penetration of NU-0129 III To assess the feasibility of giving NU-0129 as a standard treatment for recurrent GBM or GS
TERTIARY OBJECTIVES
I To analyze tumor tissue for Bcl2L12 expression levels after NU-0129 administration
II Preliminary response progression free survival PFS and overall survival OS at 6 months overall response rate ORR
OUTLINE
Patients receive NU-0129 intravenously IV over 20-50 minutes and undergo standard of care tumor resection within 8-48 hours
After completion of study treatment patients are followed up at 7 14 21 and 28 days and then every 84 days for up to 2 years
I To assess the safety of intravenous NU-0129 in patients with recurrent glioblastoma multiforme GBM or gliosarcoma GS
SECONDARY OBJECTIVES
I To analyze drug concentration in serum at specific time points after drug administration
II To demonstrate intratumoral penetration of NU-0129 III To assess the feasibility of giving NU-0129 as a standard treatment for recurrent GBM or GS
TERTIARY OBJECTIVES
I To analyze tumor tissue for Bcl2L12 expression levels after NU-0129 administration
II Preliminary response progression free survival PFS and overall survival OS at 6 months overall response rate ORR
OUTLINE
Patients receive NU-0129 intravenously IV over 20-50 minutes and undergo standard of care tumor resection within 8-48 hours
After completion of study treatment patients are followed up at 7 14 21 and 28 days and then every 84 days for up to 2 years
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 |
|---|---|---|---|
| STU00203790 | None | None | None |
| NU 16C01 | OTHER | None | None |
| P30CA060553 | NIH | None | None |
| NCI-2016-02007 | REGISTRY | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchP30CA060553 |