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Brain tumor drug implant under the microscope: how safe is it?

NCT ID NCT02684838

Knowledge-focused Sponsor: Arbor Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study followed 272 people with brain tumors who received Gliadel Wafer, a chemotherapy implant placed during surgery. Researchers tracked how long patients lived and whether the tumor came back, as well as any side effects. The goal was to see how the treatment works in real-world medical practice, not in a strict research setting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Gliadel Wafer (carmustine implant)
What this could lead to
If successful, this registry will provide real-world data on how well Gliadel Wafer works and its safety in everyday medical practice for brain tumors.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. It does not test a new treatment, only monitors existing use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

272 people

The number who actually took part.

Started

Apr 2016

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients who have been prescribed Gliadel Wafer by the physician as part of usual care

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

central nervous system cancer central nervous system neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CNS tumor

Contacts and locations

Locations

  • Albany Medical Center Hospital

    Albany, New York, 12208, United States

  • Baptist Health Paducah

    Paducah, Kentucky, 42003, United States

  • Baycare Medical Group

    Tampa, Florida, 33607, United States

  • Beacon Medical Group

    Elkhart, Indiana, 46530, United States

  • Borrow Neurological Institute

    Phoenix, Arizona, 85013, United States

  • Brain Tumor Center

    Lake Success, New York, 11042, United States

  • Crouse Neuroscience Institute

    Syracuse, New York, 13210, United States

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • David Geffen School of Medicine at UCLA; Departments of Neurosurgery and Pathology at the

    Los Angeles, California, 90095, United States

  • Depaul Hospital

    Bridgeton, Missouri, 63044, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Grand Strand Medical Center

    Myrtle Beach, South Carolina, 39572, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Jfk Medical Center

    Edison, New Jersey, 08820, United States

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287, United States

  • McLaren Bay Neurology Associates

    Bay City, Michigan, 48707, United States

  • Mount Carmel Neurosurgery

    Columbus, Ohio, 43222, United States

  • Neurological Associates of Tucson, DBA Center for Neurosciences

    Tucson, Arizona, 85718, United States

  • Oschner Medical Center

    New Orleans, Louisiana, 70121, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Spine Group Arizona At Honorhealth Scottsdale Osborn Medical Center

    Scottdale, Arizona, 85251, United States

  • Spine and Neuro Center

    Huntsville, Alabama, 35801, United States

  • St. Louis University Hospital

    St Louis, Missouri, 63110, United States

  • University of California, San Francisco Department of Neurological Surgery

    San Francisco, California, 94143, United States

  • University of Colorado School of Medicine

    Aurora, Colorado, 80045, United States

  • University of Oklahoma - Stevenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104, United States

  • University of Washington School of Medicine

    Seattle, Washington, 98195, United States

  • Vidant Medical Center

    Greenville, North Carolina, 27834, United States

  • Wake Forest Baptist Med Center

    Winston-Salem, North Carolina, 27157, United States

  • Western Regional Ctr for Brain and Spine Surgery

    Las Vegas, Nevada, 89102, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.