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Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry (VIGILANT)

ClinicalTrials.gov ID NCT02684838
Sponsor Arbor Pharmaceuticals, Inc.
Information provided by Arbor Pharmaceuticals, Inc. (Responsible Party)
Last Update Posted 2023-11-03
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Study Overview

Brief Summary
This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care.
Detailed Description
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.
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Official Title
Vigilant ObservatIon of GlIadeL WAfer ImplaNT (VIGILANT) Registry: A Multicenter, Observational Registry to Collect Information on the Safety and Effectiveness of Gliadel® Wafer (Carmustine Implant) Used in Usual Medical Practice
Conditions
CNS Tumor
Other Study ID Numbers
  • AR22.001
Study Start (Actual)
2016-04-26
Primary Completion (Estimated)
2025-12
Study Completion (Estimated)
2025-12
Enrollment (Actual)
272
Study Type
Observational

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 31 locations
United States
Alabama Locations
Huntsville, Alabama, United States, 35801

Spine and Neuro Center
Arizona Locations
Phoenix, Arizona, United States, 85013

Borrow Neurological Institute
Scottsdale, Arizona, United States, 85251

Spine Group Arizona At Honorhealth Scottsdale Osborn Medical Center
Tucson, Arizona, United States, 85718

Neurological Associates of Tucson, DBA Center for Neurosciences
California Locations
Los Angeles, California, United States, 90095

David Geffen School of Medicine at UCLA; Departments of Neurosurgery and Pathology at the
San Francisco, California, United States, 94143

University of California, San Francisco Department of Neurological Surgery
Colorado Locations
Aurora, Colorado, United States, 80045

University of Colorado School of Medicine
Florida Locations
Tampa, Florida, United States, 33607

Baycare Medical Group
Georgia Locations
Atlanta, Georgia, United States, 30322

Emory University Hospital
Indiana Locations
Elkhart, Indiana, United States, 46530

Beacon Medical Group
Kentucky Locations
Paducah, Kentucky, United States, 42003

Baptist Health Paducah
Louisiana Locations
New Orleans, Louisiana, United States, 70121

Oschner Medical Center
Maryland Locations
Baltimore, Maryland, United States, 21287

Johns Hopkins University School of Medicine
Michigan Locations
Bay City, Michigan, United States, 48707

McLaren Bay Neurology Associates
Detroit, Michigan, United States, 48202

Henry Ford Health System
Missouri Locations
Bridgeton, Missouri, United States, 63044

Depaul Hospital
Saint Louis, Missouri, United States, 63110

St. Louis University Hospital
Nevada Locations
Las Vegas, Nevada, United States, 89102

Western Regional Ctr for Brain and Spine Surgery
New Hampshire Locations
Lebanon, New Hampshire, United States, 03756

Dartmouth-Hitchcock Medical Center
New Jersey Locations
Edison, New Jersey, United States, 08820

Jfk Medical Center
New York Locations
Albany, New York, United States, 12208

Albany Medical Center Hospital
Buffalo, New York, United States, 14263

Roswell Park Cancer Institute
Lake Success, New York, United States, 11042

Brain Tumor Center
Syracuse, New York, United States, 13210

Crouse Neuroscience Institute
North Carolina Locations
Greenville, North Carolina, United States, 27834

Vidant Medical Center
Winston-Salem, North Carolina, United States, 27157

Wake Forest Baptist Med Center
Ohio Locations
Columbus, Ohio, United States, 43222

Mount Carmel Neurosurgery
Oklahoma Locations
Oklahoma City, Oklahoma, United States, 73104

University of Oklahoma - Stevenson Cancer Center
Pennsylvania Locations
Philadelphia, Pennsylvania, United States, 19104

University of Pennsylvania Health System
South Carolina Locations
Myrtle Beach, South Carolina, United States, 39572

Grand Strand Medical Center
Washington Locations
Seattle, Washington, United States, 98195

University of Washington School of Medicine
Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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.
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Study Population
Patients who have been prescribed Gliadel Wafer by the physician as part of usual care
Ages Eligible for Study
18 Years and older (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Observational Model : Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples With DNA
Biospecimen Description: Available biomarker data will be collected (e.g., MGMT, EGFR, and IDH 1&2) and exploratory patient survival analysis will be conducted based upon biomarker status.
Primary Outcome Measures
Outcome Measure Measure Description Time Frame
To evaluate the overall survival rate for patients treated with Gliadel WaferTime from Gliadel placement to deathup to 3 years
To evaluate the disease-specific survival rate for patients treated with Gliadel WaferTime from Gliadel placement to death due to CNS tumorup to 3 years
To evaluate the progression-free survival rate for patients treated with Gliadel WaferTime from Gliadel placement to diagnosis of recurrent CNS tumorup to 3 years
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
To evaluate the serious adverse events (SAEs) in patients treated with Gliadel Wafer.Frequency of SAEsup to 3 years
To evaluate events of interest (EOI) in patients treated with Gliadel Wafer.Frequency of EOIsup to 3 years
To evaluate nonserious, suspected adverse drug reactions (ADRs) in patients treated with Gliadel Wafer.frequency of ADRsup to 3 years
To evaluate change in patient health status over time via patient reported outcomes (PRO)Change in FACT-Br score from baseline to end of study participationup to 3 years
To evaluate change in patient health status over time via a practitioner/proxy reported scaleChange in KPS score from baseline to end of study participationup to 3 years
To evaluate the the reasons a physician does not insert Gliadel Wafers, in patients who were considered and consented for this Registry prior to the tumor resection procedurereasons for screen failureup to 3 years
Other Outcome Measures
Outcome Measure Measure Description Time Frame
To evaluate health care utilization though length of hospital stays for the primary procedure and any subsequent hospitalizations in patients treated with Gliadel Wafernumber of days in hospital following Gliadel insertionup to 3 years
To explore patient survival status based upon biomarker status. up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Arbor Pharmaceuticals, Inc.
Investigators
  • Study Chair:Evan Scullin, MD,Arbor Pharmaceuticals, LLC is a subsidiary of Azurity Pharmaceuticals, Inc."

Publications

From PubMed

These publications come from PubMed, a public database of scientific and medical articles. This list is automatically created by ClinicalTrials.gov Identifier (NCT Number), and these articles may or may not be about the study.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2016-02-10
First Submitted that Met QC Criteria
2016-02-12
First Posted (Estimated)
2016-02-18
Study Record Updates
Last Update Submitted that met QC Criteria
2023-11-02
Last Update Posted
2023-11-03
Last Verified
2023-11

More Information

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Keywords Provided by Arbor Pharmaceuticals, Inc.
Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
No