GliaSite 1-3 Mets Study

NCT00589212 | Completed Phase 2 DMC

• 1 other identifier: GS-700
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Metastases

Keywords

GliaSite; Brain metastases; 1-3 METS

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Overall survival, distant brain recurrence, toxicity and quality of life.

  Survival

Study Arms (1)

1

EXPERIMENTAL

Patients with 1-3 brain metastases

Device: GliaSite Radiation Therapy System

Interventions

GliaSite Radiation Therapy System 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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hologic, Inc.: lead
• Methodist Healthcare: collaborator

Study Sites (1)

Methodist University Hospital

Memphis, Tennessee, 38104, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Allen K Sills, Jr., MD

  University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 24, 2007
• First Posted: January 9, 2008
• Study Start: October 1, 2003
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2008
• Last Updated: June 11, 2008

Record last verified: 2008-06

Locations

US (1)