Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045474
Status:
COMPLETED
Last Update Posted:
2009-02-09
First Post:
2002-09-06
Brief Title:
Brachytherapy in Treating Patients With Recurrent Malignant Glioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Brachytherapy Dose Escalating Study Using the Proxima Therapeutics Inc GliaSite RTS in Patients With Recurrent Malignant Gliomas
Status:
COMPLETED
Status Verified Date:
2003-04
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 Brachytherapy uses radioactive material to kill cancer cells remaining after surgery
PURPOSE Phase I trial to study the effectiveness of brachytherapy in treating patients who have recurrent malignant glioma
PURPOSE Phase I trial to study the effectiveness of brachytherapy in treating patients who have recurrent malignant glioma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of brachytherapy using an intracavitary applicator and liquid iodine I 125 in patients with recurrent malignant glioma
Determine the acute and chronic toxicity of this therapy in these patients
OUTLINE This is a dose-escalation multicenter study
Within 3-21 days after surgical resection patients receive brachytherapy using an intracavity balloon application GliaSite with iodine I 125 solution for a total of 5-7 days
Cohorts of 5-10 patients receive escalating doses of brachytherapy until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 10 patients experience dose-limiting toxicity
Patients are followed at 4 weeks and then every 2 months for 1 year
PROJECTED ACCRUAL Approximately 20-30 patients will be accrued for this study
Determine the maximum tolerated dose of brachytherapy using an intracavitary applicator and liquid iodine I 125 in patients with recurrent malignant glioma
Determine the acute and chronic toxicity of this therapy in these patients
OUTLINE This is a dose-escalation multicenter study
Within 3-21 days after surgical resection patients receive brachytherapy using an intracavity balloon application GliaSite with iodine I 125 solution for a total of 5-7 days
Cohorts of 5-10 patients receive escalating doses of brachytherapy until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 10 patients experience dose-limiting toxicity
Patients are followed at 4 weeks and then every 2 months for 1 year
PROJECTED ACCRUAL Approximately 20-30 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| JHOC-NABTT-2106 | None | None | None |
| NABTT-2106 | None | None | None |