GliaSite 1-3 Mets Study - Full Text View

Sponsor:	Hologic, Inc.
Collaborator:	Methodist Healthcare
Information provided by:	Hologic, Inc.
ClinicalTrials.gov Identifier:	NCT00589212

Purpose

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.

Condition	Intervention	Phase
Brain Metastases	Device: GliaSite Radiation Therapy System	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer

U.S. FDA Resources

Further study details as provided by Hologic, Inc.:

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. [ 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 ]

Secondary Outcome Measures:

Overall survival, distant brain recurrence, toxicity and quality of life. [ Time Frame: Survival ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	October 2003
Study Completion Date:	March 2008
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Patients with 1-3 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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589212

Locations

United States, Tennessee
Methodist University Hospital
Memphis, Tennessee, United States, 38104

Sponsors and Collaborators

Hologic, Inc.

Methodist Healthcare

Investigators

Principal Investigator:

Allen K Sills, Jr., MD

University Hospital

More Information

No publications provided

Responsible Party:	Allen K. Sills, Jr. MD, University Hospital
ClinicalTrials.gov Identifier:	NCT00589212 History of Changes
Other Study ID Numbers:	GS-700
Study First Received:	December 24, 2007
Last Updated:	June 9, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hologic, Inc.:

GliaSite
Brain metastases
1-3 METS

Additional relevant MeSH terms:

Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms

Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012