Clinical trial NCT00589212: GliaSite 1-3 Mets Study
Official title: A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain Metastases
Keywords: GliaSite
Brain metastases
1-3 METS
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Methodist Healthcare
First posted: 2008-01-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: The primary endpoint of this study is to evaluate the 6 month and 1 year local control rate for 1-3 brain metastases treated with intracavitary radiation therapy.
timeFrame: Data collected at the time of implant, within 72 hours of implant, pre-brachytherapy, brachytherapy, radiosurgery, 1 and 3 months post brachytherapy and every 3 months thereafter
Secondary outcomes:
measure: Overall survival, distant brain recurrence, toxicity and quality of life.
timeFrame: Survival
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
Study officials:
affiliation: University Hospital
name: Allen K Sills, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References: