Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry (VIGILANT)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: CNS Tumor

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.

• Study Type: Observational
• Enrollment (Actual): 272

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Spine and Neuro Center
  • Arizona
    • 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
    • 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
    • Aurora, Colorado, United States, 80045
      • University of Colorado School of Medicine
  • Florida
    • Tampa, Florida, United States, 33607
      • BayCare Medical Group
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Indiana
    • Elkhart, Indiana, United States, 46530
      • Beacon Medical Group
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Baptist Health Paducah
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Oschner Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University School of Medicine
  • Michigan
    • Bay City, Michigan, United States, 48707
      • McLaren Bay Neurology Associates
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • Depaul Hospital
    • Saint Louis, Missouri, United States, 63110
      • St. Louis University Hospital
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Western Regional Ctr for Brain and Spine Surgery
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • Edison, New Jersey, United States, 08820
      • JFK Medical Center
  • New York
    • 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
    • Greenville, North Carolina, United States, 27834
      • Vidant Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Med Center
  • Ohio
    • Columbus, Ohio, United States, 43222
      • Mount Carmel Neurosurgery
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma - Stevenson Cancer Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 39572
      • Grand Strand Medical Center
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have been prescribed Gliadel Wafer by the physician as part of usual care

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the overall survival rate for patients treated with Gliadel Wafer	Time from Gliadel placement to death	up to 3 years
To evaluate the disease-specific survival rate for patients treated with Gliadel Wafer	Time from Gliadel placement to death due to CNS tumor	up to 3 years
To evaluate the progression-free survival rate for patients treated with Gliadel Wafer	Time from Gliadel placement to diagnosis of recurrent CNS tumor	up 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 SAEs	up to 3 years
To evaluate events of interest (EOI) in patients treated with Gliadel Wafer.	Frequency of EOIs	up to 3 years
To evaluate nonserious, suspected adverse drug reactions (ADRs) in patients treated with Gliadel Wafer.	frequency of ADRs	up 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 participation	up to 3 years
To evaluate change in patient health status over time via a practitioner/proxy reported scale	Change in KPS score from baseline to end of study participation	up 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 procedure	reasons for screen failure	up 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 Wafer	number of days in hospital following Gliadel insertion	up to 3 years
To explore patient survival status based upon biomarker status.		up to 3 years

Collaborators and Investigators

• Sponsor: Arbor Pharmaceuticals, Inc.
• Investigators: Study Chair: Evan Scullin, MD, Arbor Pharmaceuticals, LLC is a subsidiary of Azurity Pharmaceuticals, Inc."

Publications and helpful links

General Publications

• Lillehei KO, Kalkanis SN, Liau LM, Mydland DE, Olson J, Paleologos NA, Ryken T, Johnson T, Scullin E. Rationale and design of the 500-patient, 3-year, and prospective Vigilant ObservatIon of GlIadeL WAfer ImplaNT registry. CNS Oncol. 2018 Apr;7(2):CNS08. doi: 10.2217/cns-2017-0036. Epub 2017 Dec 5.

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2016
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 10, 2016
• First Submitted That Met QC Criteria: February 12, 2016
• First Posted (Estimated): February 18, 2016

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Gliadel, Carmustine wafer implant
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Neoplasms by Site; Nervous System Neoplasms; Central Nervous System Neoplasms
• Other Study ID Numbers: AR22.001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No