A Study Comparing GLIADEL to Stereotactic Radiosurgery in Metastatic Brain Disease
ConditionBrain Tumor - Metastatic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Nebraska
About this trial
This study is being done to see if adding GLIADEL to the site where the tumor was removed works as well as just having the tumor removed with radiation treatment done within six weeks after the surgery to keep the cancer from coming back.
Eligibility criteria
Qualifiers
Age 18 years or older (in states with 18 as age of majority); Age 19 years or older in Nebraska (age of majority)
Recursive partitioning analysis (RPA) class I, II or III with a Karnofsky Performance Status (KPS) of >/ 60
Known or suspected primary solid cancer with metastatic brain tumor(s) - up to four in number and up to 4 cm in size with surgical resection planned for at least one site with Gliadel placement planned for only one site
Laboratory values adequate for patient to undergo surgery safely as determined by the attending neurosurgeon (transfusion permitted to reach goals)
Disqualifiers
Prior treatment to the area of planned resection (surgery, radiation)
Prior whole brain radiation therapy
Diagnosis of lymphoma, germ cell cancer, small cell lung cancer, anaplastic thyroid cancer
Leptomeningeal disease
Trial design
Treatments tested in this trial
- Carmustine 7.7Mg Wafer
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Nebraska
Lead sponsor
Arbor Pharmaceuticals, Inc.
Collaborator
Source ClinicalTrials.gov