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A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain Metastases

Thank you

Trial Information

A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome 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

Safety Issue:

Yes

Principal Investigator

Allen K Sills, Jr., MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital

Authority:

United States: Food and Drug Administration

Study ID:

GS-700

NCT ID:

NCT00589212

Start Date:

October 2003

Completion Date:

March 2008

Related Keywords:

  • Brain Metastases
  • GliaSite
  • Brain metastases
  • 1-3 METS
  • Neoplasm Metastasis
  • Brain Neoplasms

Name

Location
Methodist University Hospital Memphis, Tennessee  38104