A Study Comparing GLIADEL to Stereotactic Radiosurgery in Metastatic Brain Disease

Summary

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

Inclusion criteria:

* 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)
* Women of childbearing potential must have a negative pregnancy test within 7 days of initiating study. (No childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries)
* Normal coagulation studies (international normalized ratio, INR, ≤ 1.3)
* Estimated survival time of ≥ 3 months (determined by the participant's primary oncologist)
* Participant is willing and able to consent and abide by the protocol

Exclusion criteria:

* 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
* Neurodegenerative disorder (e.g. dementia)
* Tumor size \> 4 cm
* Karnofsky Performance Status (KPS) \< 60
* Inability or unwillingness to co-operate with the requirements of the protocol
* Any other clinically significant medical disease or condition, laboratory abnormality or psychiatric illness that, in the Investigator's opinion, may interfere with protocol adherence or confound efficacy or safety assessment or a subject's ability to give informed consent
* Simultaneous participation in other therapeutic clinical trials
* Severe pulmonary, cardiac or other systemic disease, specifically:

  * New York Heart Association \> Grade 2 congestive heart failure within 6 months prior to study entry, unless asymptomatic and well controlled with medication
  * Uncontrolled or significant cardiovascular disease, clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or Torsades des pointes), clinically significant pulmonary disease (such as ≥ Grade 2 dyspnea, according to Common Terminology Criteria for Adverse Events 5.0)
* Participants having any other disease, either metabolic or psychological, which as per Investigator assessment may affect the participant's compliance or place the participant at higher risk of potential treatment complications
* Participant has a bleeding diathesis, or must take anticoagulants, or antiplatelet agents including non-steroidal anti-inflammatory drugs (NSAIDs) at the time of scheduled resection that cannot be stopped for surgery
* Inability to obtain MRI studies

Conditions2

Locations2 sites

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