A Randomized Trial Evaluating GLIADEL Compared to Stereotactic Radiosurgery in Subjects With Metastatic Brain Disease

0792-19-FB

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.

2020-11-06

2025-12-01

2026-12-01

Recruiting

Early phase I

100

Inclusion Criteria: 1. Age 18 years or older (Nebraska is 19 years or older) 2. Karnofsky Performance Score ≥ 70 3. RPA class I or II 4. 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 one or two tumors. 5. Adequate platelet count (≥ 100,000/mm3), transfusion permitted 6. Laboratory values adequate for patient to undergo surgery, including: (transfusion permitted to reach goals) 7. Women of childbearing potential must have a negative pregnancy test within 7 days of initiating study 8. INR ≤ 1.3 9. Estimated survival time of ≥ 3 months as determined by the patient's primary oncologist. 10. The subject is willing and able to consent to and abide by the protocol. Exclusion Criteria: 1. Prior treatment to the area of planned resection (surgery, radiation). 2. Prior whole brain radiation therapy. 3. Diagnosis of lymphoma, germ cell cancer, small cell lung cancer, anaplastic thyroid cancer. 4. Leptomeningeal disease 5. Neurodegenerative disorder (e.g. dementia). 6. Tumor size \> 4 cm. 7. RPA class III 8. Inability or unwillingness to co-operate with the requirements of the protocol 9. 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. 10. Participation in other therapeutic clinical trials 11. Severe pulmonary, cardiac or other systemic disease, specifically: 1. New York Heart Association \> Grade 2 congestive heart failure within 6 months prior to study entry, unless asymptomatic and well controlled with medication 2. Uncontrolled or significant cardiovascular disease, clinically significant ventricular arrhythmia, clinically significant pulmonary disease 12. Subjects who have any other disease, either metabolic or psychological, which as per the Investigator assessment may affect the subject's compliance or place the subject at higher risk of potential treatment complications. 13. The subject has a bleeding diathesis, or must take anticoagulants, or antiplatelet agents including NSAIDs (non-steroidal anti-inflammatory drugs), at the time of scheduled resection that cannot be stopped for surgery. 14. Inability to obtain MRI studies.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomized to either 1) the GLIADEL Arm or 2) the Standard of Care Arm (SRS post-op).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2023-08-30