Clinical Trials


Brain Tumor Trials

Bevacizumab with or without AMG 386 in patients with Recurrent Glioblastoma or Gliosarcoma
The purpose of this study is to find out the effect of bevacizumab with or without a new investigational drug, AMG 386, on you and your tumor. Bevacizumab is a protein that works by preventing new cancer-related blood vessel formation. The U.S. Food and Drug Administration (FDA) has approved bevacizumab for the treatment of recurrent glioblastoma. However, treatment with bevacizumab alone has only modestly improved overall survival in patients with this type of brain tumor. For this reason, other drugs, such as AMG 386, are being evaluated. more info >>

Principal investigator: Kevin Redmond, MD
Sponsor: RTOG 1122

DCVax®-Brain for Glioblastoma Multiforme (GBM)
The purpose of this study is to determine whether DCVax-Brain can slow the growth and recurrence of your brain tumor and whether DCVax-Brain can extend overall survival. Other goals of the study are to test the safety and activity of DCVax-Brain and to determine whether the study agent causes an immune response (how your body recognizes and defends itself against substances that appear foreign and harmful to your body) against your cancer cells as compared to standard treatment or another experimental treatment. more info >>

Principal investigator: Rekha Chaudhary, MD
Sponsor: Northwest Biotherapeutics, 020221

Rindopepimut/GM-CSF with Temozolomide for EGFRvIII-positive Glioblastoma 
The purpose of this research study is to find out whether adding an experimental vaccine product called rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug called temozolomide helps to shrink brain tumors or possibly prevents brain tumors from growing which may help patients with brain tumors live longer than treatment with temozolomide alone. more info >>

Principal investigator: Rekha Chaudhary, MD
Sponsor: Celldex Therapeutics, CDX110-04

Radiation Therapy with or without Temozolomide for Low-Grade Gliomas
This study is being conducted to compare the effects of adding the chemotherapy agent, temozolomide, to radiation for patients with low grade gliomas, WHO grade II astrocytoma, oligodendroglioma, or oligoastrocytoma.

Principal investigator: Luke Pater, MD
Sponsor: CTSU E3F05

Phase I/II Study of ABT-888 Combined with Temozolomide in Recurrent GBM

Principal investigator: Kevin Redmond, MD
Sponsor: RTOG 0929

Natural History of Postoperative Cognitive Function, Quality of Life, and Seizure Control in Patients wiht Supratentorial Low-Risk, Grade II Glioma

Principal investigator: Kevin Redmond, MD
Sponsor: RTOG 0925

Rituximab, Methotrexae, Procarbazine, Vincristine, and Cytarabine with and without Low-dose Whole-Brain Radiotherapy for Primary CNS Lymphoma

Principal investigator: Kevin Redmond, MD
Sponsor: RTOG 1114

Trental and Vitamin E for Prophalaxis of Radiation Necrosis
The purpose of this study is to determine whether the use of Trental and Vitamin E can help reduce the incidence of radiation necrosis (a lesion that usually occurs at the original tumor site) after radiosurgery. These two drugs are commonly used to treat radiation necrosis when it occurs but the hope is that these drugs can be used to prevent radiation necrosis from ever occurring.

Principal investigator: Ronald Warnick, MD
Sponsor: BTC-W1

A high throughput, sensitive and non-invasive technique for detection and quantification of EGFRvIII mutation in the peripheral blood of GBM patients

Principal investigator: Mustapha Bahassi, PhD
Sponsor: Investigator initiated

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

Neurosurgery Trials

*Pending


Stroke & Cerebrovascular Trials

CREST-2
Patients with narrowing in their carotid artery without stroke or stroke warning signs (TIAs or mini-strokes) caused by that artery are eligible to participate in a research study called CREST-2.  CREST-2 study is comparing intensive medical management alone to intensive medical management used in combination with a procedure to remove plaque buildup from the carotid artery in the neck. For more information, please visit: www.crest2trial.org

Principal Investigator: Matthew Flaherty, MD, University of Cincinnati, Neurology

Minimally Invasive Surgery + rt-PA for ICH Evacuation (MISTIE III)
The purpose of this research study is to evaluate the efficacy and safety of minimally invasive surgery (including aspiration of the clot) plus rt-PA for three days compared to conventional medical treatment. A secondary purpose is to demonstrate that end of treatment clot volume and percent of ICH reduction from surgical treatment is related to improved functional outcome as compared to medically treated subjects.

Principal investigator: Mario Zuccarello, MD
Sponsor: National Institute of Neurological Disorders and Stroke

Framing Eighteen Coils in Cerebral Aneurysms Trial (FEAT)
The purpose of this study is to compare angiographic outcomes in patients receiving 0.014-0.0155” platinum framing and filling coils followed by further aneurysm filling and finishing with less than 0.014” bare platinum coils (as deemed appropriate by the treating physician), versus those treated solely with coils less than 0.014”.

Principle investigator: Andrew Ringer, MD
Trial Sponsor: Vanderbilt University Medical Center
Financial Sponsor: Stryker (Natick, MA)


Parkinson's/Movement Disorder Trials

INTREPID study
The purpose of this study is to evaluate the safety and effectiveness of the Vercise™ Deep Brain Stimulation (DBS) system as a therapy for reducing some of the symptoms associated with Parkinson’s disease (PD) that are not adequately controlled with medication. For more information please follow this link.

Principal investigator: George Mandybur, MD

Traumatic Brain Injury Trials

Invasive and Non-Invasive Monitoring of Spreading Depolarization by ElectroCorticography in Trauma and Stroke (INSPECT)
The aim of this study is to investigate methods of recording spreading depolarizations in non-surgical patients with acute brain injury.

Principal investigator: Jed Hartings, PhD
Sponsor: Investigator initiated


Closed trials or in follow-up

  • The EVICEL® Neurosurgery Phase III Study
  • Cancer Genome Atlas Patient Enrollment and Specimen Qualification Criteria Grade II-IV Gliomas
  • Rindopepimut/GM-CSF with Temozolomide for EGFRvIII-positive Glioblastoma
  • Dasatinib or Placebo Combined with Chemoradiotherapy for Glioblastoma
  • First-in-Human Study Evaluating AMG 595 in Subjects with Recurrent Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII
  • EDGE-NEWTON: Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage
  • Condition of Approval Study for the Treatment of Lumbar Spinal Stenosis with X-STOP® PEEK IPD® in Moderately Symptomatic Patients
  • Deep Brain Stimulation (DBS) Long Term Follow-Up
    CLEAR III (Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage) Phase III
  • The Injury and Traumatic Stress (INTRuST) Consortium Neuroimagin Acquisition and Archival
  • The Injury and Traumatic Stress (INTRuST) Consortium Biorepository
  • Acoustic Neuromas: Subtotal Resection & Radiosurgery
  • Chiari Malformation Study
  • RAMP: Prospective, Randomized, Multicenter Clinical Study Comparing Axial Lumbar Interbody Fusion (AxiaLIF®) and Transforaminal Lumbar Interbody Fusion (TLIF) Spinal Procedures
  • Brain Tissue Oxygen Monitoring in Traumatic Brain Injury (BOOST II)
  • Spreading Depression in Brain Trauma (COSBID-TBI)
  • CREATE – Cognitive Remediation after Traumatic Exposure Trial
  • Adherus™ Dural Sealant in Cranial Procedures
  • Monitoring of Delayed Ischemia after Subarachnoid Hemorrhage
  • ICH Removal: Minimally Invasive Surgery + rt-PA (MISTIE)
  • Stenting versus Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS)
  • Angio-Seal™ Vascular Closure Device Following Interventional Radiology Procedures
  • PRET: Patients Prone to Recurrence after Endovascular Treatment
  • Target Imaging for Assistance in Treatment of Parkinson's
  • SLV334 in Traumatic Brain Injury
  • Clazosentan in Aneurysmal Subarachnoid Hemorrhage (CONSCIOUS-3)
  • Randomized Evaluation of Carotid Occlusion and Neurocognition (RECON)
  • Carotid Occlusion Surgery Study (COSS)
  • Clazosentan in Aneurysmal Subarachnoid Hemorrhage
  • INFUSE® Bone Graft for Spine Fusion
  • Libra™ Deep Brain Stimulator for Parkinson's Disease
  • Duragen Plus to Minimize Adhesions after Lumbar Discectomy
  • 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

Humanitarian Use Devices

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

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