GliaSite 1-3 Mets Study

June 9, 2008 updated by: Hologic, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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 Measures

Outcome Measure
Time Frame
Overall survival, distant brain recurrence, toxicity and quality of life.
Time Frame: Survival
Survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hologic, Inc.

Collaborators

Methodist Healthcare

Investigators

  • Principal Investigator: Allen K Sills, Jr., MD, University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

December 24, 2007

First Submitted That Met QC Criteria

January 8, 2008

First Posted (Estimate)

January 9, 2008

Study Record Updates

Last Update Posted (Estimate)

June 11, 2008

Last Update Submitted That Met QC Criteria

June 9, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-700

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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