Neuroscience Research

Clinical Trials

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NEURO-ONCOLOGY

Primary Site Sponsor/Study ID
NTC# 		Protocol Description Eligibility
Recurrent GBM

(Glioblastoma) 		ECOG-ACRIN

EAF-151

NCT03115333 		Change in Relative Cerebral Blood Volume as a Biomarker for Early Response to Bevacizumab in Patients with Recurrent Glioblastoma
  • Histologically proven intracranial glioblastoma or gliosarcoma at initial surgery
  • Karnofsky performance status >= 70
  • Progression of disease assessed by Revised Assessment in Neuro-Oncology (RANO) criteria
  • Patient must not have been treated previously with immunotherapies (vaccines, checkpoint inhibitors, T-cells)
  • Intratumoral hemorrhage as seen MRI may preclude inclusion
  • Progressive enhancement on MRI
  • Patients must be able to tolerate brain MRI scans with dynamic intravenous gadolinium-based contrast agent injections
  • Patient must be scheduled to receive treatment with a standard dose regimen of bevacizumab
Anaplastic Glioma or Low Grade Glioma National Cancer Institute/Alliance

N0577

NCT00887146 		Phase III Intergroup Study of Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma
  • ECOG PS: 0, 1 or 2
  • Newly diagnosed and ≤ 3 months from surgical diagnosis
  • Histological confirmation of anaplastic glioma or low grade glioma
  • Surgery (partial or gross total resection or biopsy) performed ≥ 2 weeks prior to registration with recovering from effects of surgery.
  • Tumor must show 1p/19q codeletion
Meningioma Grade II National Cancer Institute

NRG-BN003

NCT03180268 		Phase III Trial of Observation versus Irradiation for a Gross Totally Resected grade II Meningioma
  • Newly diagnosed unifocal intracranial meningioma, gross totally resection and histologically confirmed Grade II
  • GTR must be confirmed on post-operative imaging following the most recent surgery
  • Post-operative Zubrod performance status 0-1
Brain Tumor State of Florida

FCBTR

NCT00811148 		Florida Center for Brain Tumor Research
  • Adults scheduled to undergo brain surgery to remove tumor tissue
High grade glioma Tissue collection study Scripps
1R01CA229737-07

No NCT # 		Clinical Translation of Precision Medicine Testing Utilizing 3 Dimensional Primary Tumor Cell Culture
  • Patients scheduled to have surgery for removal of brain tumor.
  • Age: 18 years and older.
Leptomeningeal disease registry Penn State Registry

No NCT # 		NeMeRe, a Multi-Institutional Retrospective and Prospective Registry of Neoplastic Meningitis in Adults/td>
  • Adults 18 years and older diagnosed and treated with neoplastic meningitis.
SCLC NRG Oncology

NRG-CC003

NCT02635009 		Randomized Phase II/III Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for Small Cell Lung Cancer
  • High-grade neuroendocrine carcinoma or combined SCLC and NSCLC is permitted.
  • Prior to chemotherapy +/- thoracic radiotherapy, patients must be defined as limited-stage or extensive-stage SCLC after clinical staging evaluation.
  • Radiographic partial or complete response to chemotherapy in at least one disease site
  • Patients must have a baseline raw score greater than 2 on the HVLT-R Delayed Recall, as determined by central assessment
  • No Radiographic evidence of CNS metastases
  • Concurrent atezolizumab permitted with PCI
Brain Metastases Alliance

A071701

NCT03994796 		Genetic Testing in Guiding Treatment for Patients with Brain Metastases
  • Histologically confirmed metastatic disease to the brain from any solid tumor.
  • New or progressive brain metastases defined as any one of the following:
    • Untreated measurable lesions in patients who have received surgery and/or SRS to one or more other lesions.
    • Residual or progressive lesions after surgery if asymptomatic.
    • Patients who have had prior WBRT and.or SRS and then whose lesions have progressed by BM-RANO criteria or there are new lesions.
    • Patients who have not previously been treated with cranial radiation must be asymptomatic or neurologically stable from their CNS metastases.
  • Ability to obtain MRIs
  • Tissue available for sequencing (any brain metastasis tissue and extracranial site from any prior resection or biopsy).
Low to Intermedium Grade Gliomas NRG Oncology

NRG-BN005

NCT03180502 		Randomized Phase II Trial of Photon Therapy for Cognitive Preservation in Patients with IDH Mutant, Low to Intermediate Grade Gliomas
  • Grade II and III gliomas IDH mutant.
  • Age 18 and over.
  • Trial is open to both genders.
  • Trial is open to English and French speaking subjects.

NEUROLOGY

Primary Site Sponsor/Study ID
NTC# 		Protocol Description Eligibility
Orthostatic Hypotension in primary autonomic failure Theravance
0169

NCT03750552 		A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure
  • Meet diagnostic criteria of snOH
  • Score at least 4 on Orthostatic Hypotension Sypmtom Assessment Question 1 at randomization visit
  • PD only: have a diagnosis of PD according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria (1992)
  • MSA only: have a diagnosis of possible or probable MSA of the Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) according to The Gilman Criteria (2008)
  • PAF only: have impaired autonomic reflexes, as determined by absence of Phase IV BP overshoot after release of the Valsalva strain
Idiopathic Parkinson’s Disease Chase Therapeutics
CTC-413

NCT03683225 		A Phase 2 Study to evaluate the safety, tolerability and initial efficacy of pramipexole ER, given with aprepitant in patients with idiopathic Parkinson’s Disease
  • Males and females aged 40 - 80 years inclusive
  • Diagnosis of possible/probable idiopathic Parkinson’s Disease
  • No previous treatment with CD/LD
  • PD severity in the Hoehn & Yahr 2 - 3
Pain management (spinal chord stimulator) Abbott
ABT-CIP-10277

NCT03908476 		PROLONG Prospective, Multi-center, Open-label, Post-market Study
  • Patient has a spinal cord stimulator implanted for chronic, intractable pain.
  • Patient has inadequate pain relief from their current SCS system.
  • Patient has a pain NRS ≥ 6
  • Physician has determined that the patient's original pain is still addressable with neurostimulation
Pain management (spine surgeries) Pacira
402-C-413

NCT03927911 		A multicenter, prospective, active controlled, real world, Phase 4 study of EXPAREL in multimodal regimens compared with standard of care for postsurgical pain management in subjects undergoing lumbar posterior spine surgeries (FUSION)
  • Primary surgical indication is related to spinal degenerative disease
  • Medically cleared for elective spine surgery
  • Scheduled to undergo:
    • Elective (i.e., not emergencyz)
    • Lumbosacral (i.e., L1-S1)
    • Posterior approach with posterior instrumentation