VIGILANT: Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry
Study Details
Study Description
Brief Summary
This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care.
Condition or Disease | Intervention/Treatment | Phase |
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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
Outcome Measures
Primary Outcome Measures
- 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 disease-specific survival rate for patients treated with Gliadel Wafer [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 [up to 3 years]
Time from Gliadel placement to diagnosis of recurrent CNS tumor
Secondary Outcome Measures
- To evaluate the serious adverse events (SAEs) in patients treated with Gliadel Wafer. [up to 3 years]
Frequency of SAEs
- To evaluate events of interest (EOI) in patients treated with Gliadel Wafer. [up to 3 years]
Frequency of EOIs
- 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 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
Other Outcome Measures
- 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]
number of days in hospital following Gliadel insertion
- To explore patient survival status based upon biomarker status. [up to 3 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Male and female patients, greater than or equal to 18 years of age or age of majority in state of residence.
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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.
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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:
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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.
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Any abnormality or medical condition that, at the discretion of the Investigator, may put the patient at increased risk by participating in this registry.
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Any other reason that, in the Investigator's opinion, makes the patient unsuitable to participate in this registry.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Spine and Neuro Center | Huntsville | Alabama | United States | 35801 |
2 | Borrow Neurological Institute | Phoenix | Arizona | United States | 85013 |
3 | Spine Group Arizona At Honorhealth Scottsdale Osborn Medical Center | Scottsdale | Arizona | United States | 85251 |
4 | Neurological Associates of Tucson, DBA Center for Neurosciences | Tucson | Arizona | United States | 85718 |
5 | David Geffen School of Medicine at UCLA; Departments of Neurosurgery and Pathology at the | Los Angeles | California | United States | 90095 |
6 | University of California, San Francisco Department of Neurological Surgery | San Francisco | California | United States | 94143 |
7 | University of Colorado School of Medicine | Aurora | Colorado | United States | 80045 |
8 | Baycare Medical Group | Tampa | Florida | United States | 33607 |
9 | Emory University Hospital | Atlanta | Georgia | United States | 30322 |
10 | Beacon Medical Group | Elkhart | Indiana | United States | 46530 |
11 | Baptist Health Paducah | Paducah | Kentucky | United States | 42003 |
12 | Oschner Medical Center | New Orleans | Louisiana | United States | 70121 |
13 | Johns Hopkins University School of Medicine | Baltimore | Maryland | United States | 21287 |
14 | McLaren Bay Neurology Associates | Bay City | Michigan | United States | 48707 |
15 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
16 | Depaul Hospital | Bridgeton | Missouri | United States | 63044 |
17 | St. Louis University Hospital | Saint Louis | Missouri | United States | 63110 |
18 | Western Regional Ctr for Brain and Spine Surgery | Las Vegas | Nevada | United States | 89102 |
19 | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
20 | Jfk Medical Center | Edison | New Jersey | United States | 08820 |
21 | Albany Medical Center Hospital | Albany | New York | United States | 12208 |
22 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
23 | Brain Tumor Center | Lake Success | New York | United States | 11042 |
24 | Crouse Neuroscience Institute | Syracuse | New York | United States | 13210 |
25 | Vidant Medical Center | Greenville | North Carolina | United States | 27834 |
26 | Wake Forest Baptist Med Center | Winston-Salem | North Carolina | United States | 27157 |
27 | Mount Carmel Neurosurgery | Columbus | Ohio | United States | 43222 |
28 | University of Oklahoma - Stevenson Cancer Center | Oklahoma City | Oklahoma | United States | 73104 |
29 | University of Pennsylvania Health System | Philadelphia | Pennsylvania | United States | 19104 |
30 | Grand Strand Medical Center | Myrtle Beach | South Carolina | United States | 39572 |
31 | University of Washington School of Medicine | Seattle | Washington | United States | 98195 |
Sponsors and Collaborators
- Arbor Pharmaceuticals, Inc.
Investigators
- Study Chair: Evan Scullin, MD, Arbor Pharmaceuticals, LLC is a subsidiary of Azurity Pharmaceuticals, Inc."
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AR22-001