Back to resultsGliaSite 1-3 Mets Study
Primary Purpose
Brain Metastases
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GliaSite Radiation Therapy System
Sponsored by
About this trial
This is an interventional treatment trial for Brain Metastases focused on measuring GliaSite, Brain metastases, 1-3 METS
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.
Sites / Locations
- Methodist University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Patients with 1-3 brain metastases
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall survival, distant brain recurrence, toxicity and quality of life.
Full Information
NCT ID
NCT00589212
First Posted
December 24, 2007
Last Updated
June 9, 2008
Sponsor
Hologic, Inc.
Collaborators
Methodist Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT00589212
Brief Title
GliaSite 1-3 Mets Study
Official Title
A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hologic, Inc.
Collaborators
Methodist Healthcare
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
Keywords
GliaSite, Brain metastases, 1-3 METS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients with 1-3 brain metastases
Intervention Type
Device
Intervention Name(s)
GliaSite Radiation Therapy System
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Overall survival, distant brain recurrence, toxicity and quality of life.
Time Frame
Survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen K Sills, Jr., MD
Organizational Affiliation
University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Methodist University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
GliaSite 1-3 Mets Study
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