Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry

Active, not recruiting

• Conditions: CNS Tumor

• Registration Number: NCT02684838
• Lead Sponsor: Arbor Pharmaceuticals, Inc.

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.

Study Timeline

• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-18
• Study Start: 2016-04-26
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-25
• Last Update Posted: 2025-08-29
• Primary Completion: 2025-10
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 272

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the overall survival rate for patients treated with Gliadel Wafer	up to 3 years	Time from Gliadel placement to death
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
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

Secondary Outcome Measures

Name	Time	Method
To evaluate nonserious, suspected adverse drug reactions (ADRs) in patients treated with Gliadel Wafer.	up to 3 years	frequency of ADRs
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
To evaluate the serious adverse events (SAEs) in patients treated with Gliadel Wafer.	up to 3 years	Frequency of SAEs
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
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
To evaluate events of interest (EOI) in patients treated with Gliadel Wafer.	up to 3 years	Frequency of EOIs

Trial Locations

Locations (31)

Spine and Neuro Center; 🇺🇸 Huntsville, Alabama, United States

Borrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States

Spine Group Arizona At Honorhealth Scottsdale Osborn Medical Center; 🇺🇸 Scottdale, Arizona, United States

Neurological Associates of Tucson, DBA Center for Neurosciences; 🇺🇸 Tucson, Arizona, United States

David Geffen School of Medicine at UCLA; Departments of Neurosurgery and Pathology at the; 🇺🇸 Los Angeles, California, United States

University of California, San Francisco Department of Neurological Surgery; 🇺🇸 San Francisco, California, United States

University of Colorado School of Medicine; 🇺🇸 Aurora, Colorado, United States

Baycare Medical Group; 🇺🇸 Tampa, Florida, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Beacon Medical Group; 🇺🇸 Elkhart, Indiana, United States

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