Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry

NCT02684838 | Completed

• 1 other identifier: AR22.001
• Study Type: observational
• Target: 272
• Locations: 1 country
• Sites: 31

Brief Summary

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

Conditions

CNS Tumor

Keywords

Gliadel, Carmustine wafer implant

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• To evaluate the serious adverse events (SAEs) in patients treated with Gliadel Wafer.

  up to 3 years

• To evaluate events of interest (EOI) in patients treated with Gliadel Wafer.

  up to 3 years

• To evaluate nonserious, suspected adverse drug reactions (ADRs) in patients treated with Gliadel Wafer.

  up to 3 years

• To evaluate change in patient health status over time via patient reported outcomes (PRO)

  up to 3 years

• To evaluate change in patient health status over time via a practitioner/proxy reported scale

  up to 3 years

Other Outcomes (2)

• 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

• To explore patient survival status based upon biomarker status.

  up to 3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• Male and female patients, greater than or equal to 18 years of age or age of majority in state of residence.
• 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.
• 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.

You may not qualify if:

• 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.
• Any abnormality or medical condition that, at the discretion of the Investigator, may put the patient at increased risk by participating in this registry.
• Any other reason that, in the Investigator's opinion, makes the patient unsuitable to participate in this registry.

Sponsors & Collaborators

• Arbor Pharmaceuticals, Inc.: lead

Study Sites (31)

Spine and Neuro Center

Huntsville, Alabama, 35801, United States

Location

Borrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Spine Group Arizona At Honorhealth Scottsdale Osborn Medical Center

Scottdale, Arizona, 85251, United States

Location

Neurological Associates of Tucson, DBA Center for Neurosciences

Tucson, Arizona, 85718, United States

Location

David Geffen School of Medicine at UCLA; Departments of Neurosurgery and Pathology at the

Los Angeles, California, 90095, United States

Location

University of California, San Francisco Department of Neurological Surgery

San Francisco, California, 94143, United States

Location

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

Baycare Medical Group

Tampa, Florida, 33607, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Beacon Medical Group

Elkhart, Indiana, 46530, United States

Location

Baptist Health Paducah

Paducah, Kentucky, 42003, United States

Location

Oschner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

McLaren Bay Neurology Associates

Bay City, Michigan, 48707, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Depaul Hospital

Bridgeton, Missouri, 63044, United States

Location

St. Louis University Hospital

St Louis, Missouri, 63110, United States

Location

Western Regional Ctr for Brain and Spine Surgery

Las Vegas, Nevada, 89102, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Jfk Medical Center

Edison, New Jersey, 08820, United States

Location

Albany Medical Center Hospital

Albany, New York, 12208, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Brain Tumor Center

Lake Success, New York, 11042, United States

Location

Crouse Neuroscience Institute

Syracuse, New York, 13210, United States

Location

Vidant Medical Center

Greenville, North Carolina, 27834, United States

Location

Wake Forest Baptist Med Center

Winston-Salem, North Carolina, 27157, United States

Location

Mount Carmel Neurosurgery

Columbus, Ohio, 43222, United States

Location

University of Oklahoma - Stevenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Grand Strand Medical Center

Myrtle Beach, South Carolina, 39572, United States

Location

University of Washington School of Medicine

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• 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.

  PMID: 29206049 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Central Nervous System Neoplasms

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 18, 2016
• Study Start: April 26, 2016
• Primary Completion: June 23, 2025
• Study Completion: June 23, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (31)