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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02684838
Other study ID # AR22.001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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