- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003574
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
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.
Study Overview
Status
Conditions
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama Comprehensive Cancer Center
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital - Atlanta
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Oncology Center
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital Cancer Center
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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North Carolina
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Winston-Salem, North Carolina, United States, 27157-1082
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Cancer Center
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Texas
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San Antonio, Texas, United States, 78284-7811
- University of Texas Health Science Center at San Antonio
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically confirmed malignant glioma: Anaplastic astrocytoma Anaplastic oligodendroglioma Glioblastoma multiforme Unifocal disease Progressive or recurrent disease following radiation therapy and/or chemotherapy Must be eligible for surgical resection of the tumor mass No unresectable leptomeningeal spread or ventricular invasion outside the radiation treatment volume No exophytic ventricular tumors Must have a maximal cross-sectional diameter enhancing tumor greater than 2.0 cm but not greater than 5.0 cm by preoperative MRI Ratio of major axes of the tumor should not exceed 1.5 No marked edema by preoperative MRI or CT that cannot be corrected by tumor resection
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No uncontrolled hypertension, angina pectoris, or uncontrolled cardiac dysrhythmia Other: Not pregnant or nursing Fertile patients must use effective contraception No serious concurrent infection or other medical illness No prior or concurrent malignancy within 5 years except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: See Disease Characteristics No concurrent chemotherapy At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 months since prior radiotherapy and recovered Surgery: See Disease Characteristics Other: At least 4 weeks since prior use of medical device No concurrent investigational agents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Stephen Tatter, MD, PhD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000066641
- NABTT-9801
- JHOC-NABTT-9801
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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