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Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry (VIGILANT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02684838
Recruitment Status : Recruiting
First Posted : February 18, 2016
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
CNS Tumor

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : March 2016
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Carmustine




Primary Outcome Measures :
  1. To evaluate the overall survival rate for patients treated with Gliadel Wafer [ Time Frame: up to 3 years ]
    Time from Gliadel placement to death

  2. 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

  3. 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


Secondary Outcome Measures :
  1. To evaluate the serious adverse events (SAEs) in patients treated with Gliadel Wafer. [ Time Frame: up to 3 years ]
    Frequency of SAEs

  2. To evaluate events of interest (EOI) in patients treated with Gliadel Wafer. [ Time Frame: up to 3 years ]
    Frequency of EOIs

  3. To evaluate nonserious, suspected adverse drug reactions (ADRs) in patients treated with Gliadel Wafer. [ Time Frame: up to 3 years ]
    frequency of ADRs

  4. To evaluate change in patient health status over time via patient reported outcomes (PRO) [ Time Frame: up to 3 years ]
    Change in FACT-Br score from baseline to end of study participation

  5. To evaluate change in patient health status over time via a practitioner/proxy reported scale [ Time Frame: up to 3 years ]
    Change in KPS score from baseline to end of study participation

  6. 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 ]
    reasons for screen failure


Other Outcome Measures:
  1. To evaluate health care utilization though length of hospital stays for the primary procedure and any subsequent hospitalizations in patients treated with Gliadel Wafer [ Time Frame: up to 3 years ]
    number of days in hospital following Gliadel insertion

  2. To explore patient survival status based upon biomarker status. [ Time Frame: up to 3 years ]

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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have been prescribed Gliadel Wafer by the physician as part of usual care
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684838


Contacts
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Contact: Kim Petranick, BA, MS 800-381-7878 ext 4388 Vigilant@MapiGroup.com
Contact: Tania D Johnson, RN, BSN 404-496-5903 tjohnson@arborpharma.com

  Show 36 Study Locations
Sponsors and Collaborators
Arbor Pharmaceuticals, Inc.
Investigators
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Study Chair: Evan Scullin, MD Arbor Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Arbor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02684838     History of Changes
Other Study ID Numbers: AR22-001
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arbor Pharmaceuticals, Inc.:
Gliadel, Carmustine wafer implant
Additional relevant MeSH terms:
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Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Carmustine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents