Trials / Completed
CompletedNCT00003574
Radiation Therapy in Treating Patients With Progressive or Recurrent Malignant Brain Tumors
A Multi-Center, Open-Label Clinical Study to Evaluate the Safety and Performance of the Proxima GliaSite RTS, a Radiation Delivery System, in Patients With Recurrent Malignant Brain Tumors Undergoing Surgical Resection
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- New Approaches to Brain Tumor Therapy Consortium · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients who are undergoing surgical removal of progressive or recurrent malignant brain tumors.
Detailed description
OBJECTIVES: I. Evaluate the safety of the GliaSite RTS in patients with progressive or recurrent malignant brain tumors undergoing surgical resection. II. Evaluate the performance of the GliaSite RTS in these patients. OUTLINE: This is an open label, multicenter study. Patients undergo surgical resection of the tumor followed by surgical placement of the GliaSite device in the resection cavity. One to 2 weeks after surgery, patients receive brachytherapy consisting of an infusion of iodine I-125. The I-125 solution is removed and collected 5-7 days later. The device is surgically removed within 24 hours. Patients are followed at 24 hours, 14 days, and 1 year post device removal. PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | surgical procedure | |
| RADIATION | brachytherapy | |
| RADIATION | intraoperative radiation therapy | |
| RADIATION | iodine I 125 |
Timeline
- Start date
- 1999-04-01
- Completion
- 2004-06-01
- First posted
- 2004-06-16
- Last updated
- 2013-06-21
Locations
9 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00003574. Inclusion in this directory is not an endorsement.