GliaSite 1-3 Mets Study
Completed · Phase 2
Conditions studied: Brain Metastases
In brief
This study has been designed to compile information on the efficacy of the GliaSite RTS combined with radiosurgery in the treatment of newly diagnosed metastatic brain tumors.
Key facts
- Study ID
- NCT00589212
- Run by
- Hologic, Inc.
- People needed
- 50
- Starts
- 2003-10-01
- Expected to finish
- 2008-03-01
- Last updated by the study team
- 2008-06-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Have 1-3 newly diagnosed supratentorial metastatic brain lesions with at least one being dominant and eligible for surgical resection as visualized on enhanced MRI scan
- Have histological evidence of metastatic carcinoma on intraoperative pathology (frozen section) or final pathology report
- Have a Karnofsky Performance Status (KPS) >=70
- Have systemic disease which is judged to be stable and has been staged within the last 6 weeks
- Have a life expectancy of >= 6 month, based upon extent of systemic disease
- Be at least 18 years of age Give informed consent (or have legal representative give informed consent)
You may not qualify if…
- Be receiving or have plans to receive conventional or investigational systemic agents for the metastatic brain tumor.
- Be receiving or have plans to receive external beam radiation therapy to the brain.
- Have received prior conventional or investigational systemic agents, including the use of Gliadel Wafers or Temodar, for the treatment of the brain metastasis.
- Be pregnant or breast-feeding.
- Have uncontrolled hypertension, unstable angina pectoris, evidence of uncontrolled cardiac dysrhythmia.
- Have other serious concurrent infection or other medical illness which would jeopardize the ability of the patient to safely undergo resection and brachytherapy.
- Have histology of lymphoma or small-cell lung cancer.
Where it is running
- Methodist University Hospital — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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