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GliaSite 1-3 Mets Study

NCT ID: NCT00589212

Last Updated: 2008-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2008-03-31

Brief Summary

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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

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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

Conditions

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Brain Metastases

Keywords

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GliaSite Brain metastases 1-3 METS

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Patients with 1-3 brain metastases

Group Type EXPERIMENTAL

GliaSite Radiation Therapy System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Methodist Healthcare

OTHER

Sponsor Role collaborator

Hologic, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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University Hospital

Principal Investigators

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Allen K Sills, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital

Locations

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Methodist University Hospital

Memphis, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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GS-700

Identifier Type: -

Identifier Source: org_study_id

NCT00096252

Identifier Type: -

Identifier Source: nct_alias