GliaSite 1-3 Mets Study

Brain Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00589212
• Other study ID #: GS-700
• Status: Completed
• Phase: Phase 2
• First received: December 24, 2007
• Last updated: June 9, 2008
• Start date: October 2003
• Est. completion date: March 2008

Study information

• Verified date: June 2008
• Source: Hologic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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

Other known NCT identifiers

• NCT00096252

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2008
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

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.

Locations

Country	Name	City	State
United States	Methodist University Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Hologic, Inc.	Methodist Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		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	Yes
Secondary	Overall survival, distant brain recurrence, toxicity and quality of life.		Survival	Yes