Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031083
Status:
COMPLETED
Last Update Posted:
2020-11-17
First Post:
2002-02-20
Brief Title:
Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III Grade IV Gliomas
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Multi-center Open Label Two Part Dose Escalation Study to Determine the Tolerability of Interferon-Beta Gene Transfer BG00001 in the Treatment of Recurrent or Progressive Grade III and Grade IV Gliomas
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:
In this study an investigational replication-defective recombinant adenovirus expressing the interferon-beta gene BG00001 will be directly injected into tumors in patients with recurrent Grade III and Grade IV Gliomas in order to deliver the hIFN-beta gene The purpose of the study is to evaluate the safety and any harmful effects of injection of BG00001 into brain tumors Also this study will help determine whether the virus carrying the beta interferon gene will enter brain tumor cells and cause the cancer cells to die This study will require one hospital admission for the actual procedure of drug administration All other visits will be conducted on an out-patient basis
Detailed Description:
None
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 |
|---|---|---|---|
| 0101-453 | None | None | None |