Viewing Study NCT00045474



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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
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

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