Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry

Study Purpose

This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Signed informed consent, by the patient or a legally acceptable representative, obtained before any registry-related activities are undertaken. The informed consent must be signed within 14 calendar days after surgery. 2. Male and female patients, greater than or equal to 18 years of age or age of majority in state of residence. 3. Patients planning to receive Gliadel Wafer, or having already received Gliadel Wafer and having signed consent to enroll in the registry within 14 calendar days after surgery for treatment of central nervous system (CNS) tumor(s), or are currently enrolled in another study where they received Gliadel Wafer. 4. Signed release form, by the patient or a legally acceptable representative, permitting abstraction of the patient's medical records at Baseline and during participation in the registry.

Exclusion Criteria:

1. The patient is enrolled in an interventional clinical trial, in which treatment for CNS tumor(s) is managed through a protocol that excludes Gliadel Wafer treatment. 2. Any abnormality or medical condition that, at the discretion of the Investigator, may put the patient at increased risk by participating in this registry. 3. Any other reason that, in the Investigator's opinion, makes the patient unsuitable to participate in this registry.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02684838
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Arbor Pharmaceuticals, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Evan Scullin, MD
Principal Investigator Affiliation Arbor Pharmaceuticals, LLC is a subsidiary of Azurity Pharmaceuticals, Inc."
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

CNS Tumor
Additional Details

This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care. Data will be collected on the safety and effectiveness of treatment with Gliadel Wafer perioperatively and ongoing during regular office visits up to 3-years. Patients enrolled in this registry will be asked to complete a questionnaire (Functional Assessment of Cancer Therapy-Brain [FACT-Br]) about their well-being and clinicians will complete the Karnofsky Performance Status (KPS) during office visits.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Spine and Neuro Center, Huntsville, Alabama

Status

Recruiting

Address

Spine and Neuro Center

Huntsville, Alabama, 35801

Site Contact

Toni Kelley

TONI@SPINEANDNEURO.COM

256-533-8081

Borrow Neurological Institute, Phoenix, Arizona

Status

Recruiting

Address

Borrow Neurological Institute

Phoenix, Arizona, 85013

Site Contact

Regina Becker

becker.regina@mayo.edu

480-342-6079 #26079

Scottsdale, Arizona

Status

Recruiting

Address

Spine Group Arizona At Honorhealth Scottsdale Osborn Medical Center

Scottsdale, Arizona, 85251

Site Contact

Marlinda Gurule

mgurule@honorhealth.com

480-593-4736

Tucson, Arizona

Status

Terminated

Address

Neurological Associates of Tucson, DBA Center for Neurosciences

Tucson, Arizona, 85718

Los Angeles, California

Status

Recruiting

Address

David Geffen School of Medicine at UCLA; Departments of Neurosurgery and Pathology at the

Los Angeles, California, 90095

Site Contact

EMMA Billingslea-Yoon

EBillingslea@mednet.ucla.edu

310-267-2621

University of California - Irvine, Orange, California

Status

Withdrawn

Address

University of California - Irvine

Orange, California, 92868

San Francisco, California

Status

Terminated

Address

University of California, San Francisco Department of Neurological Surgery

San Francisco, California, 94143

Aurora, Colorado

Status

Recruiting

Address

University of Colorado School of Medicine

Aurora, Colorado, 80045

Site Contact

Jennifer Maitlen, RN, BSN

jennifer.maitlen@ucdenver.edu

303-724-1995

Morton Plant Hospital, Clearwater, Florida

Status

Withdrawn

Address

Morton Plant Hospital

Clearwater, Florida, 33756

Baycare Medical Group, Tampa, Florida

Status

Recruiting

Address

Baycare Medical Group

Tampa, Florida, 33607

Site Contact

KATE COLGAIN

Katelynn.Colgain@baycare.org

813-356-7168

Atlanta Va Hospital, Atlanta, Georgia

Status

Withdrawn

Address

Atlanta Va Hospital

Atlanta, Georgia, 30033

Emory University Hospital, Atlanta, Georgia

Status

Recruiting

Address

Emory University Hospital

Atlanta, Georgia, 30322

Site Contact

ASHLEY TRUMBULL

ashley.lynn.trumbull@emory.edu

404-778-3969

Beacon Medical Group, Elkhart, Indiana

Status

Recruiting

Address

Beacon Medical Group

Elkhart, Indiana, 46530

Site Contact

JONI ROUSCULP

psims@beaconhealthsystem.org

574-647-7883

Baptist Health Paducah, Paducah, Kentucky

Status

Recruiting

Address

Baptist Health Paducah

Paducah, Kentucky, 42003

Site Contact

BETTY KUIPER

Bkuiper@BHSI.com

270-575-2928

Oschner Medical Center, New Orleans, Louisiana

Status

Recruiting

Address

Oschner Medical Center

New Orleans, Louisiana, 70121

Site Contact

NEYDIN OSORIO

neydin.tejeda@ochsner.org

504-703-5577

Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287

Site Contact

LYNN SMITH

lsmith36@jhmi.edu

410-550-7391

McLaren Bay Neurology Associates, Bay City, Michigan

Status

Recruiting

Address

McLaren Bay Neurology Associates

Bay City, Michigan, 48707

Site Contact

LISA WINTERS

Lisa.Winters@mclaren.org

989-894-9520

Henry Ford Health System, Detroit, Michigan

Status

Terminated

Address

Henry Ford Health System

Detroit, Michigan, 48202

Depaul Hospital, Bridgeton, Missouri

Status

Terminated

Address

Depaul Hospital

Bridgeton, Missouri, 63044

St. Louis University Hospital, Saint Louis, Missouri

Status

Recruiting

Address

St. Louis University Hospital

Saint Louis, Missouri, 63110

Site Contact

VIRGINIA WAMSER

WAMSERVL@SLU.EDU

314-977-4751

Las Vegas, Nevada

Status

Terminated

Address

Western Regional Ctr for Brain and Spine Surgery

Las Vegas, Nevada, 89102

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756

Site Contact

PRABHA LOGANATHAN

Prabhavathi.Loganathan@hitchcock.org

603-650-4378

Jfk Medical Center, Edison, New Jersey

Status

Recruiting

Address

Jfk Medical Center

Edison, New Jersey, 08820

Albany Medical Center Hospital, Albany, New York

Status

Recruiting

Address

Albany Medical Center Hospital

Albany, New York, 12208

Site Contact

KATY RAGEN

REGANK@MAIL.AMC.EDU

518-262-5938

Roswell Park Cancer Institute, Buffalo, New York

Status

Recruiting

Address

Roswell Park Cancer Institute

Buffalo, New York, 14263

Site Contact

ELONGIA FARRELL

Elongia.Farrell@RoswellPark.org

716-845-3114

Brain Tumor Center, Lake Success, New York

Status

Recruiting

Address

Brain Tumor Center

Lake Success, New York, 11042

Site Contact

NICK KLEINER

NKleiner@northwell.edu

716-845-3114

Crouse Neuroscience Institute, Syracuse, New York

Status

Recruiting

Address

Crouse Neuroscience Institute

Syracuse, New York, 13210

Site Contact

EVELYN VOURA

Evelynvoura@crousemed.com

917-903-8071

Vidant Medical Center, Greenville, North Carolina

Status

Recruiting

Address

Vidant Medical Center

Greenville, North Carolina, 27834

Site Contact

TAMEKA LITTLE

Tameka.Little@Vidanthealth.com

252-847-5517

Wake Forest Baptist Med Center, Winston-Salem, North Carolina

Status

Recruiting

Address

Wake Forest Baptist Med Center

Winston-Salem, North Carolina, 27157

Site Contact

WENDY JENKINS

WEJENKIN@WAKEHEALTH.EDU

336-716-3842

Mount Carmel Neurosurgery, Columbus, Ohio

Status

Terminated

Address

Mount Carmel Neurosurgery

Columbus, Ohio, 43222

Oklahoma City, Oklahoma

Status

Terminated

Address

University of Oklahoma - Stevenson Cancer Center

Oklahoma City, Oklahoma, 73104

University of Pennsylvania Health System, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104

Grand Strand Medical Center, Myrtle Beach, South Carolina

Status

Terminated

Address

Grand Strand Medical Center

Myrtle Beach, South Carolina, 39572

Vanderbilt Univ Medical Center, Nashville, Tennessee

Status

Withdrawn

Address

Vanderbilt Univ Medical Center

Nashville, Tennessee, 37232

Seattle, Washington

Status

Recruiting

Address

University of Washington School of Medicine

Seattle, Washington, 98195

Site Contact

RONALD MIMS

rmims@uw.edu

206-221-0968

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