Trials / Completed
CompletedNCT00045474
Brachytherapy in Treating Patients With Recurrent Malignant Glioma
Phase I Brachytherapy Dose Escalating Study Using the Proxima Therapeutics, Inc. GliaSite RTS in Patients With Recurrent Malignant Gliomas
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | adjuvant therapy | |
| RADIATION | iodine I 125 |
Timeline
- Start date
- 2002-10-01
- First posted
- 2003-01-27
- Last updated
- 2009-02-09
Locations
9 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00045474. Inclusion in this directory is not an endorsement.