Brain Tumor - MetastaticPhase 2NCT04222062
A Study Comparing GLIADEL to Stereotactic Radiosurgery in Metastatic Brain Disease
A Phase 2 study testing Carmustine 7.7Mg Wafer in people with Brain Tumor - Metastatic, run by University of Nebraska at 2 sites in United States.
Trial summary
This study is being done to see if adding GLIADEL to the site where the tumor was removed works as well as just having the tumor removed with radiation treatment done within six weeks after the surgery to keep the cancer from coming back. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor - Metastatic
- What is being tested?
- Carmustine 7.7Mg Wafer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Nov 2020to Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age 18 years or older (in states with 18 as age of majority); Age 19 years or older in Nebraska (age of majority)
- Recursive partitioning analysis (RPA) class I, II or III with a Karnofsky Performance Status (KPS) of >/ 60
- Known or suspected primary solid cancer with metastatic brain tumor(s) - up to four in number and up to 4 cm in size with surgical resection planned for at least one site with Gliadel placement planned for only one site
- Laboratory values adequate for patient to undergo surgery safely as determined by the attending neurosurgeon (transfusion permitted to reach goals)
- Women of childbearing potential must have a negative pregnancy test within 7 days of initiating study. (No childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries)
- Normal coagulation studies (international normalized ratio, INR, ≤ 1.3)
- Estimated survival time of ≥ 3 months (determined by the participant's primary oncologist)
- Participant is willing and able to consent and abide by the protocol
Who cannot join
- Prior treatment to the area of planned resection (surgery, radiation)
- Prior whole brain radiation therapy
- Diagnosis of lymphoma, germ cell cancer, small cell lung cancer, anaplastic thyroid cancer
- Leptomeningeal disease
- Neurodegenerative disorder (e.g. dementia)
- Tumor size > 4 cm
Show all 16Show fewer
- Karnofsky Performance Status (KPS) < 60
- Inability or unwillingness to co-operate with the requirements of the protocol
- Any other clinically significant medical disease or condition, laboratory abnormality or psychiatric illness that, in the Investigator's opinion, may interfere with protocol adherence or confound efficacy or safety assessment or a subject's ability to give informed consent
- Simultaneous participation in other therapeutic clinical trials
- Severe pulmonary, cardiac or other systemic disease, specifically:
- New York Heart Association > Grade 2 congestive heart failure within 6 months prior to study entry, unless asymptomatic and well controlled with medication
- Uncontrolled or significant cardiovascular disease, clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or Torsades des pointes), clinically significant pulmonary disease (such as ≥ Grade 2 dyspnea, according to Common Terminology Criteria for Adverse Events 5.0)
- Participants having any other disease, either metabolic or psychological, which as per Investigator assessment may affect the participant's compliance or place the participant at higher risk of potential treatment complications
- Participant has a bleeding diathesis, or must take anticoagulants, or antiplatelet agents including non-steroidal anti-inflammatory drugs (NSAIDs) at the time of scheduled resection that cannot be stopped for surgery
- Inability to obtain MRI studies
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Henry Ford
Detroit, Michigan, 48202
Coordinator, 313-874-7513, aqasraw1@hfhs.org
Ian Lee, MD
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Michele R Aizenberg Ansari, MD, 402-559-9614, maizenberg@unmc.edu
About this study
Official title: A Randomized Trial Evaluating GLIADEL Compared to Stereotactic Radiosurgery in Subjects With Metastatic Brain Disease
This study is being done to see if adding GLIADEL to the site where the tumor was removed works as well as just having the tumor removed with radiation treatment done within six weeks after the surgery to keep the cancer from coming back.
Read the detailed description
This study is being done to assess the efficacy of GLIADEL, a local chemotherapy, in preventing local recurrence of a metastatic brain tumor compared to stereotactic radiosurgery (SRS) after resection.
100 adult participants with one to four metastatic brain tumors with one tumor needing resection will be enrolled. Participants with prior radiation, lymphoma, small cell, germ cell, unknown primary, or anaplastic thyroid diagnoses will be ineligible. Life expectancy should be greater than 3 months.
Participants will be randomized at the time of surgery to 1) GLIADEL placement at the time of resection or 2) SRS post-operatively to the resection cavity. Any other tumors (up to three) will have SRS as their primary treatment after surgery. SRS will take place within 6 weeks from surgery.
Participants will be evaluated pre-operatively with Magnetic resonance imaging (MRI) brain and neuropsychological testing and will have immediate post-op MRI for extent of resection (EOR) determination. Participants will have SRS to the resection cavity if no GLIADEL was placed and all will have SRS to any other lesions. They will be followed at set intervals to evaluate for local recurrence and neurocognitive changes. The genome of the metastatic brain tumor will be compared to their primary and germline for identification of alterations.
- Conditions
- Brain Tumor - Metastatic
- Being tested
- Carmustine 7.7Mg Wafer
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carmustine 7.7Mg WaferDrug
Also called GLIADEL
GLIADEL wafers will be placed to cover tumor bed immediately after tumor removal.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Arm | No intervention | The tumor will be removed surgically. Within 6 weeks after surgery, the resection will be treated with stereotactic radiosurgery (SRS). |
| GLIADEL Arm | Experimental | Once the tumor has been removed, GLIADEL wafers will be applied to the resection cavity. The number of wafers used will be determined by the size of the cavity. Enough wafers should be used so that as much of the cavity is covered as possible. Receives: Drug: Carmustine 7.7Mg Wafer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of GLIADEL compared to Stereotactic Radiosurgery (SRS)
The primary outcome is to evaluate the efficacy of GLIADEL local chemotherapy compared to Stereotactic Radiosurgery (SRS) in preventing local recurrence after resection of a metastatic brain tumor (local recurrence at surgical site).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start6 Nov 2020
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumor - MetastaticStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to either 1) the GLIADEL Arm or 2) the Standard of Care Arm (SRS post-op).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Arbor Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Michele Aizenberg, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222062
- Sponsor's protocol ID
- 0792-19-FB
- Status last verified
- Apr 2026
- First submitted
- 6 Jan 2020
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Evaluating GLIADEL Compared to Stereotactic Radiosurgery in Subjects With Metastatic Brain Disease
- ClinicalTrials.gov ID
- NCT04222062
- Acronym / sponsor ID
- 0792-19-FB
- Conditions
- Brain Tumor - Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Arbor Pharmaceuticals, Inc.
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 9 Jan 2020 (actual)
- 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 study is being done to see if adding GLIADEL to the site where the tumor was removed works as well as just having the tumor removed with radiation treatment done within six weeks after the surgery to keep the cancer from coming back.
Detailed description
This study is being done to assess the efficacy of GLIADEL, a local chemotherapy, in preventing local recurrence of a metastatic brain tumor compared to stereotactic radiosurgery (SRS) after resection.
100 adult participants with one to four metastatic brain tumors with one tumor needing resection will be enrolled. Participants with prior radiation, lymphoma, small cell, germ cell, unknown primary, or anaplastic thyroid diagnoses will be ineligible. Life expectancy should be greater than 3 months.
Participants will be randomized at the time of surgery to 1) GLIADEL placement at the time of resection or 2) SRS post-operatively to the resection cavity. Any other tumors (up to three) will have SRS as their primary treatment after surgery. SRS will take place within 6 weeks from surgery.
Participants will be evaluated pre-operatively with Magnetic resonance imaging (MRI) brain and neuropsychological testing and will have immediate post-op MRI for extent of resection (EOR) determination. Participants will have SRS to the resection cavity if no GLIADEL was placed and all will have SRS to any other lesions. They will be followed at set intervals to evaluate for local recurrence and neurocognitive changes. The genome of the metastatic brain tumor will be compared to their primary and germline for identification of alterations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized to either 1) the GLIADEL Arm or 2) the Standard of Care Arm (SRS post-op).
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Arm | No intervention | –The tumor will be removed surgically. Within 6 weeks after surgery, the resection will be treated with stereotactic radiosurgery (SRS). |
| GLIADEL Arm | Experimental | Drug: Carmustine 7.7Mg WaferOnce the tumor has been removed, GLIADEL wafers will be applied to the resection cavity. The number of wafers used will be determined by the size of the cavity. Enough wafers should be used so that as much of the cavity is covered as possible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or older (in states with 18 as age of majority); Age 19 years or older in Nebraska (age of majority)
- Recursive partitioning analysis (RPA) class I, II or III with a Karnofsky Performance Status (KPS) of >/ 60
- Known or suspected primary solid cancer with metastatic brain tumor(s) - up to four in number and up to 4 cm in size with surgical resection planned for at least one site with Gliadel placement planned for only one site
- Laboratory values adequate for patient to undergo surgery safely as determined by the attending neurosurgeon (transfusion permitted to reach goals)
- Women of childbearing potential must have a negative pregnancy test within 7 days of initiating study. (No childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries)
Key exclusion criteria (16 listed)
- Prior treatment to the area of planned resection (surgery, radiation)
- Prior whole brain radiation therapy
- Diagnosis of lymphoma, germ cell cancer, small cell lung cancer, anaplastic thyroid cancer
- Leptomeningeal disease
- Neurodegenerative disorder (e.g. dementia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carmustine 7.7Mg WaferAlso: GLIADELGLIADEL wafers will be placed to cover tumor bed immediately after tumor removal. | Drug | GLIADEL Arm |
Primary outcome
Efficacy of GLIADEL compared to Stereotactic Radiosurgery (SRS)
Time frame: 12 months
The primary outcome is to evaluate the efficacy of GLIADEL local chemotherapy compared to Stereotactic Radiosurgery (SRS) in preventing local recurrence after resection of a metastatic brain tumor (local recurrence at surgical site).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- 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.
Michele Aizenberg, MD principal investigator
University of Nebraska
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carmustine 7.7Mg Wafer in people with Brain Tumor - Metastatic, run by University of Nebraska at 2 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 8 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Coordinator (402-559-0963, IITOffice@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of GLIADEL compared to Stereotactic Radiosurgery (SRS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.