Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry

CNS Tumor Clinical Trial

— VIGILANT  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02684838
• Other study ID #: AR22.001
• Status: Active, not recruiting
• Start date: April 26, 2016
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Arbor Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 272
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• CNS Tumor

Locations

Country	Name	City	State
United States	Albany Medical Center Hospital	Albany	New York
United States	Emory University Hospital	Atlanta	Georgia
United States	University of Colorado School of Medicine	Aurora	Colorado
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	McLaren Bay Neurology Associates	Bay City	Michigan
United States	Depaul Hospital	Bridgeton	Missouri
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Mount Carmel Neurosurgery	Columbus	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	Jfk Medical Center	Edison	New Jersey
United States	Beacon Medical Group	Elkhart	Indiana
United States	Vidant Medical Center	Greenville	North Carolina
United States	Spine and Neuro Center	Huntsville	Alabama
United States	Brain Tumor Center	Lake Success	New York
United States	Western Regional Ctr for Brain and Spine Surgery	Las Vegas	Nevada
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	David Geffen School of Medicine at UCLA; Departments of Neurosurgery and Pathology at the	Los Angeles	California
United States	Grand Strand Medical Center	Myrtle Beach	South Carolina
United States	Oschner Medical Center	New Orleans	Louisiana
United States	University of Oklahoma - Stevenson Cancer Center	Oklahoma City	Oklahoma
United States	Baptist Health Paducah	Paducah	Kentucky
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	Borrow Neurological Institute	Phoenix	Arizona
United States	St. Louis University Hospital	Saint Louis	Missouri
United States	University of California, San Francisco Department of Neurological Surgery	San Francisco	California
United States	Spine Group Arizona At Honorhealth Scottsdale Osborn Medical Center	Scottsdale	Arizona
United States	University of Washington School of Medicine	Seattle	Washington
United States	Crouse Neuroscience Institute	Syracuse	New York
United States	Baycare Medical Group	Tampa	Florida
United States	Neurological Associates of Tucson, DBA Center for Neurosciences	Tucson	Arizona
United States	Wake Forest Baptist Med Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Arbor Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	To explore patient survival status based upon biomarker status.		up to 3 years
Primary	To evaluate the overall survival rate for patients treated with Gliadel Wafer	Time from Gliadel placement to death	up to 3 years
Primary	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
Primary	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	To evaluate the serious adverse events (SAEs) in patients treated with Gliadel Wafer.	Frequency of SAEs	up to 3 years
Secondary	To evaluate events of interest (EOI) in patients treated with Gliadel Wafer.	Frequency of EOIs	up to 3 years
Secondary	To evaluate nonserious, suspected adverse drug reactions (ADRs) in patients treated with Gliadel Wafer.	frequency of ADRs	up to 3 years
Secondary	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
Secondary	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
Secondary	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