Clinical trial NCT02684838: Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: CNS Tumor
Keywords: Gliadel, Carmustine wafer implant
Lead sponsor: Arbor Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-18
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been prescribed Gliadel Wafer by the physician as part of usual care

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.

Eligibility 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.

Primary outcomes:
measure: To evaluate the overall survival rate for patients treated with Gliadel Wafer
timeFrame: up to 3 years
measure: To evaluate the disease-specific survival rate for patients treated with Gliadel Wafer
timeFrame: up to 3 years
measure: To evaluate the progression-free survival rate for patients treated with Gliadel Wafer
timeFrame: up to 3 years
Secondary outcomes:
measure: To evaluate the serious adverse events (SAEs) in patients treated with Gliadel Wafer.
timeFrame: up to 3 years
measure: To evaluate events of interest (EOI) in patients treated with Gliadel Wafer.
timeFrame: up to 3 years
measure: To evaluate nonserious, suspected adverse drug reactions (ADRs) in patients treated with Gliadel Wafer.
timeFrame: up to 3 years
measure: To evaluate change in patient health status over time via patient reported outcomes (PRO)
timeFrame: up to 3 years
measure: To evaluate change in patient health status over time via a practitioner/proxy reported scale
timeFrame: up to 3 years
measure: 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
timeFrame: up to 3 years
Other outcomes:
measure: To evaluate health care utilization though length of hospital stays for the primary procedure and any subsequent hospitalizations in patients treated with Gliadel Wafer
timeFrame: up to 3 years
measure: To explore patient survival status based upon biomarker status.
timeFrame: up to 3 years
Locations:
city: Huntsville
country: United States
facility: Spine and Neuro Center
state: Alabama
city: Phoenix
country: United States
facility: Borrow Neurological Institute
state: Arizona
city: Scottsdale
country: United States
facility: Spine Group Arizona At Honorhealth Scottsdale Osborn Medical Center
state: Arizona
city: Tucson
country: United States
facility: Neurological Associates of Tucson, DBA Center for Neurosciences
state: Arizona
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA; Departments of Neurosurgery and Pathology at the
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco Department of Neurological Surgery
state: California
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
city: Tampa
country: United States
facility: Baycare Medical Group
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Elkhart
country: United States
facility: Beacon Medical Group
state: Indiana
city: Paducah
country: United States
facility: Baptist Health Paducah
state: Kentucky
city: New Orleans
country: United States
facility: Oschner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Bay City
country: United States
facility: McLaren Bay Neurology Associates
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Bridgeton
country: United States
facility: Depaul Hospital
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University Hospital
state: Missouri
city: Las Vegas
country: United States
facility: Western Regional Ctr for Brain and Spine Surgery
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Edison
country: United States
facility: Jfk Medical Center
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center Hospital
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Lake Success
country: United States
facility: Brain Tumor Center
state: New York
city: Syracuse
country: United States
facility: Crouse Neuroscience Institute
state: New York
city: Greenville
country: United States
facility: Vidant Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Med Center
state: North Carolina
city: Columbus
country: United States
facility: Mount Carmel Neurosurgery
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma - Stevenson Cancer Center
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Grand Strand Medical Center
state: South Carolina
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
Study officials:
affiliation: Arbor Pharmaceuticals, LLC is a subsidiary of Azurity Pharmaceuticals, Inc."
name: Evan Scullin, MD
role: STUDY_CHAIR
References:
citation: 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.