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Treatment of Resectable Malignant Brain Tumors

This study has been terminated.
(Sponsor decision to terminate study.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00415467
First received: December 22, 2006
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

The goals of this study are to evaluate each of the following items:

  1. Time to recurrence in patients receiving brachytherapy with the GliaSite RTS
  2. Overall survival (OS) in patients with malignant brain tumors who are undergoing surgical resection and brachytherapy treatment with the GliaSite® Radiation Therapy System (RTS).
  3. Incidence of serious adverse events in patients treated with GliaSite RTS

Condition Intervention Phase
Brain Tumor
 Device: GliaSite Radiation Therapy System
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV GliaSite® Radiation Therapy System Registry Protocol for the Treatment of Resectable Malignant Brain Tumors

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer
U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Time to Recurrence of Brain Tumor (anywhere in brain) [ Time Frame: From brachytherapy to assessments at 1 and 3 months after brachytherapy then every 3 months after that or until documented brain tumor recurrence. ] [ Designated as safety issue: No ]
    Time to recurrence of brain tumor determined for each patient from the time at the end date of brachytherapy with the GliaSite RTS until the date of documented brain tumor recurrence.


Secondary Outcome Measures:
  • Overall Patient Survival [ Time Frame: Time from completion of the GliaSite procedure to death by any cause (time in months). ] [ Designated as safety issue: No ]
    Overall survival determined as time from end date of brachytherapy with the GliaSite RTS until the date of death, including occurrences of death due to CNS causes and by deaths due to non-CNS causes. In the time to event analyses, if the event is not reached, participant censored at last date known to be without the event of interest (recurrence-free or alive). Median time-to-event determined by Kaplan-Meier methods.


Enrollment: 13
Study Start Date: January 2005
Study Completion Date: July 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GliaSite Radiation Therapy System (RTS)
Surgical removal of brain tumor followed by GliaSite RTS targeted brachytherapy to the specific brain tumor site
 Device: GliaSite Radiation Therapy System
Radiation delivery system that provides brachytherapy targeted to a specific site in the brain, to see its effects to the surrounding area where the tumor was located.
Other Name: GliaSite RTS

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must have histologically proven malignant brain tumor
  2. Patient must be a candidate for surgical resection of the tumor mass.
  3. Patient must not be pregnant or breast-feeding. All patients with the potential for pregnancy should be counseled and requested to follow acceptable birth control methods to avoid conception.
  4. Patient must sign informed consent form

Exclusion Criteria:

1. Serious concurrent infection or medical illness which could jeopardize the ability of the patient to receive the GliaSite catheter with reasonable safety.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415467

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Anita Mahajan, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
UT MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00415467     History of Changes
Other Study ID Numbers: 2003-0942
Study First Received: December 22, 2006
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Brain Tumor
Radiation Therapy System
GliaSite RTS

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013