GliaSite 1-3 Mets Study

This study has been completed.
Sponsor:
Collaborator:
Methodist Healthcare
Information provided by:
Hologic, Inc.
ClinicalTrials.gov Identifier:
NCT00589212
First received: December 24, 2007
Last updated: June 9, 2008
Last verified: June 2008

December 24, 2007
June 9, 2008
October 2003
March 2007   (final data collection date for primary outcome 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. [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00589212 on ClinicalTrials.gov Archive Site
Overall survival, distant brain recurrence, toxicity and quality of life. [ Time Frame: Survival ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
GliaSite 1-3 Mets Study
A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases

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.

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

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Brain Metastases
Device: GliaSite Radiation Therapy System
GliaSite RTS is designed to deliver intracavitary radiation therapy for brain tumors. Following surgical resection, the balloon catheter is inflated to fill the cavity and Iotrex radiotherapy solution infused. It is a single applicator system that provides a uniform and conformal dose to the resection cavity.
Experimental: 1
Patients with 1-3 brain metastases
Intervention: Device: GliaSite Radiation Therapy System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
March 2008
March 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00589212
GS-700
Yes
Allen K. Sills, Jr. MD, University Hospital
Hologic, Inc.
Methodist Healthcare
Principal Investigator: Allen K Sills, Jr., MD University Hospital
Hologic, Inc.
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP