CNS TumorVIGILANTNCT02684838
Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry
An observational study of CNS Tumor, run by Arbor Pharmaceuticals, Inc. at 31 sites in United States.
Trial summary
This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CNS Tumor
- How many people
- 272 participants
- Where
- 31 sitesUnited States
- Study dates
- 26 Apr 2016to 23 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been prescribed Gliadel Wafer by the physician as part of usual care
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Albany Medical Center Hospital
Albany, New York, 12208
Emory University Hospital
Atlanta, Georgia, 30322
University of Colorado School of Medicine
Aurora, Colorado, 80045
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
McLaren Bay Neurology Associates
Bay City, Michigan, 48707
Depaul Hospital
Bridgeton, Missouri, 63044
Roswell Park Cancer Institute
Buffalo, New York, 14263
Mount Carmel Neurosurgery
Columbus, Ohio, 43222
Henry Ford Health System
Detroit, Michigan, 48202
Jfk Medical Center
Edison, New Jersey, 08820
Beacon Medical Group
Elkhart, Indiana, 46530
Vidant Medical Center
Greenville, North Carolina, 27834
Spine and Neuro Center
Huntsville, Alabama, 35801
Brain Tumor Center
Lake Success, New York, 11042
Western Regional Ctr for Brain and Spine Surgery
Las Vegas, Nevada, 89102
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
David Geffen School of Medicine at UCLA; Departments of Neurosurgery and Pathology at the
Los Angeles, California, 90095
Grand Strand Medical Center
Myrtle Beach, South Carolina, 39572
Oschner Medical Center
New Orleans, Louisiana, 70121
University of Oklahoma - Stevenson Cancer Center
Oklahoma City, Oklahoma, 73104
Baptist Health Paducah
Paducah, Kentucky, 42003
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Borrow Neurological Institute
Phoenix, Arizona, 85013
University of California, San Francisco Department of Neurological Surgery
San Francisco, California, 94143
Spine Group Arizona At Honorhealth Scottsdale Osborn Medical Center
Scottdale, Arizona, 85251
University of Washington School of Medicine
Seattle, Washington, 98195
St. Louis University Hospital
St Louis, Missouri, 63110
Crouse Neuroscience Institute
Syracuse, New York, 13210
Baycare Medical Group
Tampa, Florida, 33607
Neurological Associates of Tucson, DBA Center for Neurosciences
Tucson, Arizona, 85718
Wake Forest Baptist Med Center
Winston-Salem, North Carolina, 27157
About this study
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
This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care.
Read the 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.
- Conditions
- CNS Tumor
- Keywords
- Gliadel, Carmustine wafer implant
- Medical subject headings
- Central Nervous System Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the overall survival rate for patients treated with Gliadel Wafer
Time from Gliadel placement to death
Measured: 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
Measured: 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
Measured: up to 3 years
Secondary outcomes (6)
To evaluate the serious adverse events (SAEs) in patients treated with Gliadel Wafer.
Frequency of SAEs
Measured: up to 3 years
To evaluate events of interest (EOI) in patients treated with Gliadel Wafer.
Frequency of EOIs
Measured: up to 3 years
To evaluate nonserious, suspected adverse drug reactions (ADRs) in patients treated with Gliadel Wafer.
frequency of ADRs
Measured: up to 3 years
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
Measured: up to 3 years
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
Measured: up to 3 years
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
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study start26 Apr 2016
- Primary completion23 Jun 2025
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CNS TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbor Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684838
- Sponsor's protocol ID
- AR22.001
- Acronym
- VIGILANT
- Status last verified
- Nov 2025
- First submitted
- 10 Feb 2016
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29206049
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02684838
- Acronym / sponsor ID
- VIGILANT / AR22.001
- Conditions
- CNS Tumor
- Keywords
- Gliadel, Carmustine wafer implant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Arbor Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2016 (actual)
- Primary completion
- 23 Jun 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been prescribed Gliadel Wafer by the physician as part of usual care
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the overall survival rate for patients treated with Gliadel Wafer
Time frame: up to 3 years
Time from Gliadel placement to death
To evaluate the disease-specific survival rate for patients treated with Gliadel Wafer
Time frame: up to 3 years
Time from Gliadel placement to death due to CNS tumor
To evaluate the progression-free survival rate for patients treated with Gliadel Wafer
Time frame: up to 3 years
Time from Gliadel placement to diagnosis of recurrent CNS tumor
6 secondary outcomes
To evaluate the serious adverse events (SAEs) in patients treated with Gliadel Wafer.
Time frame: up to 3 years
To evaluate events of interest (EOI) in patients treated with Gliadel Wafer.
Time frame: up to 3 years
To evaluate nonserious, suspected adverse drug reactions (ADRs) in patients treated with Gliadel Wafer.
Time frame: up to 3 years
To evaluate change in patient health status over time via patient reported outcomes (PRO)
Time frame: up to 3 years
To evaluate change in patient health status over time via a practitioner/proxy reported scale
Time frame: up to 3 years
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
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Derived from this study: PubMed 29206049Lillehei 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CNS Tumor, run by Arbor Pharmaceuticals, Inc. at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the overall survival rate for patients treated with Gliadel Wafer (time frame: up to 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02684838, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.