GliaSite 1-3 Mets Study

Hologic

Status and phase

Completed

Phase 2

Conditions

Brain Metastases

Treatments

Device: GliaSite Radiation Therapy System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00589212

GS-700

Details and patient eligibility

About

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.

Full description

Data relevant to the evaluation the effectiveness of the GliaSite RTS for a resected dominant brain metastases will be collected. The GliaSite RTS is a radionuclide applicator and liquid radionuclide (Iotrex) designed to deliver intracavitary radiation therapy for resected brain tumors. In this case, it will irradiate the resected margins. Brain metastases not surgically removed will be then treated with radiosurgery

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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.