VIGILANT: Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry

Sponsor
Arbor Pharmaceuticals, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02684838
Collaborator
(none)
271
31
91.2
8.7
0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    271 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Vigilant ObservatIon of GlIadeL WAfer ImplaNT (VIGILANT) Registry: A Multicenter, Observational Registry to Collect Information on the Safety and Effectiveness of GliadelĀ® Wafer (Carmustine Implant) Used in Usual Medical Practice
    Actual Study Start Date :
    Apr 26, 2016
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the overall survival rate for patients treated with Gliadel Wafer [up to 3 years]

      Time from Gliadel placement to death

    2. To evaluate the disease-specific survival rate for patients treated with Gliadel Wafer [up to 3 years]

      Time from Gliadel placement to death due to CNS tumor

    3. To evaluate the progression-free survival rate for patients treated with Gliadel Wafer [up to 3 years]

      Time from Gliadel placement to diagnosis of recurrent CNS tumor

    Secondary Outcome Measures

    1. To evaluate the serious adverse events (SAEs) in patients treated with Gliadel Wafer. [up to 3 years]

      Frequency of SAEs

    2. To evaluate events of interest (EOI) in patients treated with Gliadel Wafer. [up to 3 years]

      Frequency of EOIs

    3. To evaluate nonserious, suspected adverse drug reactions (ADRs) in patients treated with Gliadel Wafer. [up to 3 years]

      frequency of ADRs

    4. To evaluate change in patient health status over time via patient reported outcomes (PRO) [up to 3 years]

      Change in FACT-Br score from baseline to end of study participation

    5. To evaluate change in patient health status over time via a practitioner/proxy reported scale [up to 3 years]

      Change in KPS score from baseline to end of study participation

    6. 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 [up to 3 years]

      reasons for screen failure

    Other Outcome Measures

    1. To evaluate health care utilization though length of hospital stays for the primary procedure and any subsequent hospitalizations in patients treated with Gliadel Wafer [up to 3 years]

      number of days in hospital following Gliadel insertion

    2. To explore patient survival status based upon biomarker status. [up to 3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Spine and Neuro Center Huntsville Alabama United States 35801
    2 Borrow Neurological Institute Phoenix Arizona United States 85013
    3 Spine Group Arizona At Honorhealth Scottsdale Osborn Medical Center Scottsdale Arizona United States 85251
    4 Neurological Associates of Tucson, DBA Center for Neurosciences Tucson Arizona United States 85718
    5 David Geffen School of Medicine at UCLA; Departments of Neurosurgery and Pathology at the Los Angeles California United States 90095
    6 University of California, San Francisco Department of Neurological Surgery San Francisco California United States 94143
    7 University of Colorado School of Medicine Aurora Colorado United States 80045
    8 Baycare Medical Group Tampa Florida United States 33607
    9 Emory University Hospital Atlanta Georgia United States 30322
    10 Beacon Medical Group Elkhart Indiana United States 46530
    11 Baptist Health Paducah Paducah Kentucky United States 42003
    12 Oschner Medical Center New Orleans Louisiana United States 70121
    13 Johns Hopkins University School of Medicine Baltimore Maryland United States 21287
    14 McLaren Bay Neurology Associates Bay City Michigan United States 48707
    15 Henry Ford Health System Detroit Michigan United States 48202
    16 Depaul Hospital Bridgeton Missouri United States 63044
    17 St. Louis University Hospital Saint Louis Missouri United States 63110
    18 Western Regional Ctr for Brain and Spine Surgery Las Vegas Nevada United States 89102
    19 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756
    20 Jfk Medical Center Edison New Jersey United States 08820
    21 Albany Medical Center Hospital Albany New York United States 12208
    22 Roswell Park Cancer Institute Buffalo New York United States 14263
    23 Brain Tumor Center Lake Success New York United States 11042
    24 Crouse Neuroscience Institute Syracuse New York United States 13210
    25 Vidant Medical Center Greenville North Carolina United States 27834
    26 Wake Forest Baptist Med Center Winston-Salem North Carolina United States 27157
    27 Mount Carmel Neurosurgery Columbus Ohio United States 43222
    28 University of Oklahoma - Stevenson Cancer Center Oklahoma City Oklahoma United States 73104
    29 University of Pennsylvania Health System Philadelphia Pennsylvania United States 19104
    30 Grand Strand Medical Center Myrtle Beach South Carolina United States 39572
    31 University of Washington School of Medicine Seattle Washington United States 98195

    Sponsors and Collaborators

    • Arbor Pharmaceuticals, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arbor Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT02684838
    Other Study ID Numbers:
    • AR22-001
    First Posted:
    Feb 18, 2016
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Arbor Pharmaceuticals, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 30, 2022