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
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Obsolete Identifiers: NCT00096252
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 August 28, 2014