Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114309
Status:
UNKNOWN
Last Update Posted:
2009-04-03
First Post:
2005-06-13
Brief Title:
131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma
Sponsor:
TransMolecular
Organization:
TransMolecular
Study Overview
Official Title:
A Phase II Open-Label Multiple-Dose Study of Intracavitary Administered 131-I-TM-601 in Adult Patients With Recurrent High-Grade Glioma
Status:
UNKNOWN
Status Verified Date:
2009-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 drug is being developed to treat a type of brain cancer glioma This study was developed to evaluate the safety time to disease progression and survival rates after treatment
Detailed Description:
This phase II trial was designed in two sequences The first sequence which is now complete to accrual was an open-label dose escalation multi-dose study and treated 12 evaluable patients with high-grade glioma
The second sequence is currently open and accruing eligible subjects with high-grade glioma The trial is an open-label randomized study and will accrue a total of 54 evaluable patients Eligible subjects will be randomized to receive either 3 or 6 injections of 131-I labeled TM-601 131-I-TM-601 in weekly intervals at the dose determined in the first sequence of the trial Patients will undergo debulking surgery and placement of a ventricular access device into the tumor cavity for administration of 131I-TM-601 Patients who participated in the first sequence are not eligible to participate in the second sequence of the study
High-grade gliomas include glioblastoma multiforme anaplastic astrocytoma oligoastrocytoma or gliosarcoma
Patients will undergo follow-up clinical examinations and magnetic resonance imaging MRI assessments at defined intervals until 12 months after the first study dose
The second sequence is currently open and accruing eligible subjects with high-grade glioma The trial is an open-label randomized study and will accrue a total of 54 evaluable patients Eligible subjects will be randomized to receive either 3 or 6 injections of 131-I labeled TM-601 131-I-TM-601 in weekly intervals at the dose determined in the first sequence of the trial Patients will undergo debulking surgery and placement of a ventricular access device into the tumor cavity for administration of 131I-TM-601 Patients who participated in the first sequence are not eligible to participate in the second sequence of the study
High-grade gliomas include glioblastoma multiforme anaplastic astrocytoma oligoastrocytoma or gliosarcoma
Patients will undergo follow-up clinical examinations and magnetic resonance imaging MRI assessments at defined intervals until 12 months after the first study dose
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