Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003410
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Motexafin Gadolinium With MRI-Guided Surgery in Treating Patients With High-Grade Gliomas
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pilot Trial of Gadolium Texaphyrin for Magnetic Resonance Imaging-Guided Resection of High Grade Gliomas
Status:
COMPLETED
Status Verified Date:
2006-05
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:
RATIONALE New imaging procedures such as the use of gadolinium texaphyrin with MRI may improve the ability to detect the extent of gliomas
PURPOSE Phase I trial to study the effectiveness of gadolinium texaphyrin used with MRI-guided surgery in treating patients with high-grade glioma
PURPOSE Phase I trial to study the effectiveness of gadolinium texaphyrin used with MRI-guided surgery in treating patients with high-grade glioma
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of gadolinium texaphyrin as a tumor retained contrast agent in MRI guided neurosurgery in patients with radiological diagnosis of high grade glioma I Determine the intratumoral pharmacology and quantitative pharmacokinetics of gadolinium texaphyrin using MRI imaging in these patients II Develop a scale that will relate MRI signal characteristics from intratumoral gadolinium texaphyrin with absolute intratumoral levels of gadolinium texaphyrin in these patients III Investigate the distribution of gadolinium texaphyrin in high grade gliomas in comparison with biologically active tumor as delineated by elevated choline-containing material detected by proton magnetic resonance spectroscopic imaging
OUTLINE This is a dose escalation study Patients receive gadolinium texaphyrin by IV infusion 20 minutes to 2 hours prior to magnetic resonance imaging and surgery The maximum tolerated dose for a single dose of gadolinium texaphyrin is determined by cohorts of 3 patients who are treated at one of five escalating doses Patients in each cohort are followed for a minimum of 4 weeks each before the next cohort begins If good contrast enhancement is assessed at the fourth dose level cohort 4 dose escalation stops Patients are followed at days 1 and 2 at weeks 1 2 and 4 and at 3 months after surgery
PROJECTED ACCRUAL A total of 6-18 patients will be accrued into this study
OUTLINE This is a dose escalation study Patients receive gadolinium texaphyrin by IV infusion 20 minutes to 2 hours prior to magnetic resonance imaging and surgery The maximum tolerated dose for a single dose of gadolinium texaphyrin is determined by cohorts of 3 patients who are treated at one of five escalating doses Patients in each cohort are followed for a minimum of 4 weeks each before the next cohort begins If good contrast enhancement is assessed at the fourth dose level cohort 4 dose escalation stops Patients are followed at days 1 and 2 at weeks 1 2 and 4 and at 3 months after surgery
PROJECTED ACCRUAL A total of 6-18 patients will be accrued into this study
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 |
|---|---|---|---|
| NCI-T97-0107 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066422 | REGISTRY | None | None |
| UCLA-HSPC-970904301 | None | None | None |
| UCLA-HSPC-970904302 | None | None | None |