Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040573
Status:
COMPLETED
Last Update Posted:
2009-03-31
First Post:
2002-06-29
Brief Title:
Safety and Tolerability Study of 131I-TM-601 to Treat Adult Patients With Recurrent Glioma
Sponsor:
TransMolecular
Organization:
TransMolecular
Study Overview
Official Title:
A Phase III Open Label Single Dose Study of Intracavitary Administered 131I-TM-601 in Adult Patients With Recurrent High-Grade Glioma
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This drug is being developed to treat a type of brain cancer glioma This study was designed to determine a safe and well tolerated dose Patients must have had prior treatment for their glioma and be eligible for removal of their recurring tumor
Detailed Description:
This is an open label single-dose study to be conducted in 18 evaluable patients with recurrent high-grade glioma Patient will undergone debulking surgery and ventricular access device placement into the tumor cavity for administration of 131I-TM-601 High-grade glioma includes glioblastoma multiforme anaplastic astrocytoma anaplastic oligo-astrocytoma and gliosarcoma The amount of 131I will remain constant Three doses of TM-601 will be administered using a dose escalating scheme
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