Brain Tumor Trials

Acoustic Neuromas: Subtotal Resection & Radiosurgery
The purpose of this study is to analyze the effectiveness of subtotal removal followed by radiosurgery compared to complete removal for patients with large acoustic neuromas.

Principal investigator: Philip Theodosopoulos, MD

Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma
This randomized phase III trial is studying temozolomide and radiation therapy to compare how well they work when given together with or without bevacizumab in treating patients with newly diagnosed glioblastoma or gliosarcoma.

Principal investigator: Margie Gerena Lewis, MD
Sponsor: Radiation Therapy Oncology Group (RTOG 0825)

Surgery with Implantable BCNU Polymer followed by Post-operative Irinotecan and Bevacizumab for Recurrent Resectable Glioblastoma
Patients who have been diagnosed with recurrent disease that can be at least partially removed by surgery are eligible. The two chemotherapy drugs (irinotecan and bevacizumab) used in this study are not approved for use in brain tumors.

Principal investigator: Margie Gerena Lewis, MD

Dasatinib in Recurrent Glioblastoma Multiforme
Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well dasatinib works in treating patients with recurrent glioblastoma multiforme or gliosarcoma.

Principal investigator: Margie Gerena Lewis, MD
Sponsor: Radiation Therapy Oncology Group (RTOG 0627)

PTK-787 in Recurrent or Progressive Meningiomas
The purpose of this study is to determine the positive and negative effects of an investigational drug called PTK-787 on meningiomas. PTK-787 may interfere with the growth of new blood vessels by blocking the supply of nutrients and oxygen and therefore stop tumor growth and possibly shrink the tumor.

Principal investigator: Margie Gerena Lewis, MD
Sponsor: National Cancer Institute (NCI)

Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole Brain Radiotherapy for Brain Metastasis
The purpose of this study is to compare the positive and negative effects of memantine with a placebo on memory and thinking in participants receiving whole brain radiotherapy to treat brain metastasis.

Principal investigator: Kevin Redmond, MD
Sponsor: National Cancer Institute (NCI)

Temozolomide Chemoradiotherapy for Low-Grade Gliomas
The purpose of this study is to determine whether a drug called temozolomide combined with radiation will control the tumor longer than radiation alone or radiation combined with other chemotherapy drugs used in previous clinical trials. more info >>

Principal investigator: Kevin Redmond, MD

Head and Spine Tissue Bank and Registry
The purpose of this study is to collect tissue samples from patients with tumors involving the head, brain and spine. Researchers will then use the tissue samples at some point in the future to study how to prevent, diagnose and better treat these tumors.

Principal investigator: Christopher McPherson, MD

Ohio Brain Tumor Study
The study is a tissue bank that includes four sites in the State of Ohio.

Principal investigator: Christopher McPherson, MD

Stroke & Cerebrovascular Trials

ICH Removal: Minimally Invasive Surgery + rt-PA (MISTIE)
The purpose of this study is to evaluate the use of rt-PA (a clot-busting drug) after a surgical procedure to remove a blood clot from the brain after an intracerebral hemorrhage (ICH).

Principal investigator: Mario Zuccarello, MD
Sponsor: National Institutes of Health (NIH)

Carotid Occlusion Surgery Study (COSS)
The purpose is to determine if Extracranial-Intracranial Bypass can reduce the chance of a subsequent stroke in someone who has complete blockage in one main artery and has already suffered a small stroke. more info >>

Principal investigator: Mario Zuccarello, MD
Sponsor: National Institutes of Health (NIH)

Randomized Evaluation of Carotid Occlusion and Neurocognition (RECON)
The purpose of this study is to determine the relationship between mental functioning and blood flow in the brain among patients that have already consented to participate in the Carotid Occlusion Surgery Study (COSS)

Principal investigator: Mario Zuccarello, MD
Sponsor: National Institutes of Health (NIH)

Wingspan™ Stent for Blocked Brain Arteries
The purpose of this study is to monitor the effectiveness of the Wingspan Stent System to open arteries in the brain that have become blocked by a clot or narrowed by plaque.

Principal investigator: Andrew Ringer, MD

Neuroform™ Stent for Wide-neck Aneurysms
The purpose of this study is to monitor the effectiveness of the Neuroform Stent in treating wide-neck aneurysms in the brain.

Principal investigator: Andrew Ringer, MD
Sponsor: Boston Scientific

Onyx Liquid Embolic System HD-500
The purpose of this study is to monitor the effectiveness of the Onyx Liquid Embolic System in treating aneurysms in the brain.

Principal investigator: Andrew Ringer, MD

CORDIS ENTERPRISE™ Vascular Reconstruction Device & Delivery System
The purpose of this study is to monitor the effectiveness of the Cordis Enterprise Device in treating aneurysms in the brain.

Principal investigator: Andrew Ringer, MD
Sponsor: Codman & Shurtleff

Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS)
The purpose of Phase 1 of the research study is to see whether intensive medical therapy only or intensive medical therapy plus angioplasty and stenting will have the most success in preventing patients with a narrowed brain artery from having a stroke. The purpose of phase 2 is to get more information on how the stent works over a longer period of time after being used to treat patients with a narrowed brain artery.

Principal investigator: Andrew Ringer, MD
Sponsor: National Institutes of Health (NIH)

Clazosentan in Aneurysmal Subarachnoid Hemorrhage (CONSCIOUS-2)
The purpose of this research study is to evaluate whether the research drug can reduce the risk of developing vasospasm after subarachnoid hemorrhage and determine the side effects associated with the research study drug (clazosentan).

Principal investigator: Mario Zuccarello, MD
Sponsor: Actelion

Familial Intracranial Aneurysm (FIA) Study
The purpose of this study is to identify the genes that may be important in the development of intracranial aneurysms. more info >>

Principal investigator: Joseph Broderick, MD
Sponsor: National Institutes of Health (NIH)

Spine Trials

INFUSE® Bone Graft for Spine Fusion
The purpose of this study is to determine the safety and effectiveness of a polymer implant (PEEK cage) and bone morphogenetic proteins (BMP) to create a spinal fusion in the neck (cervical) area of the spine. Fusion is the joining together of two separate bones into one and is a treatment option for cervical degenerative disc disease. more info >>

Principal investigator: Robert Bohinski, MD, PhD
Sponsor: Medtronic Sofamor Danek, Inc.

Duragen Plus to Minimize Adhesions after Lumbar Discectomy
The purpose of this study is to evaluate the safety and effectiveness of DuraGen Plus® as an adhesion barrier in spinal surgery to reduce the extent of scar tissue formation and pain in comparison to a control group receiving standard care.

Principal investigator: Charles Kuntz, IV, MD
Sponsor: Integra Lifesciences Corporation

Parkinson's Trials

Target Imaging for Assistance in Treatment of Parkinson's
The purpose of this study is to determine whether sophisticated new imaging technologies can help pinpoint placement of deep brain stimulation electrodes in patients with Parkinson's Disease.

Principal investigator: George Mandybur, MD
Sponsor: Davis Phinney Foundation

Libra™ Deep Brain Stimulator for Parkinson's Disease
The purpose of this study is to determine whether the Libra™ deep brain stimulation (DBS) system can help reduce some of the symptoms of Parkinson's disease that are not adequately controlled with medication.

Principal investigator: George Mandybur, MD
Sponsor: Advanced Neuromodulation Systems, Inc. (ANS)

Traumatic Brain Injury Trials

Spreading Depression
The purpose of this study is to examine a form of brain seizure activity and its impact on recovery from brain injury.

Principal investigator: Jed Hartings, PhD
Sponsor: Department of Defense

Closed trials in follow-up

• Gliadel Wafers & Permanent I-125 Seeds for Glioblastoma
• Biomarkers for Subarachnoid Induced Cerebral Vasospasm
• IVH Removal: Intraventricular rt-PA
• Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST)
• Comparison of Dura Sealants for Cranial Surgery
• New Spinal Sealant for Dura Repair
• Eon™ Spinal Cord Stimulator for Chronic Back & Leg Pain
• Prevention of Disability after Spinal Cord Injury (Cethrin)
• Prevention of Seizures after Brain Injury
• Near-infrared Spectroscopy to Detect Bleeding in the Brain
• Brain Stimulation for Arm/Hand Weakness After a Stroke
• Assessment of Surgery for Cervical Spondylotic Myelopathy
• Lumbar Stabilization using the AxiaLif system
  
• Evaluation of the PathFinder™ System for Pedicle Screw Insertion
  
• Evaluation of the CODA Expandable Fusion Cage
  
• FlexiCore™ Artificial Disc for the Treatment of Discogenic Pain
  
• ChillerStrip™ Hypothermia System for Aneurysm Surgery
  
• Safety and Tolerability of DTI-015 in Patients with Recurrent GBM
  
• Hemicraniectomy and Durotomy Upon Deterioration from Infarction Related Swelling (HeADDFIRST)
  
• Evaluation of ForSite Device to Measure Pupillary Size
  
• National Acute Brain Injury Study: Hypothermia II
  
• Prevention of Vasospasm & New Infarction after Aneurysmal SAH Following Administration of Clazosentan
  
• Evaluation of a Single IV Dose of Dexanabinol in Patients Suffering from Severe TBI
  
• Procrit® (Epoetin Alfa) Administered Perioperatively Versus Standard of Care in Blood Conservation in Subjects Undergoing Major Elective Spinal Surgery
  
• DuraSeal™ System as an Adjunct to Sutured Dural Repair During Cranial Surgery