Recruiting
Phase 2

GLIADEL vs. Stereotactic Radiosurgery

Sponsor:

University of Nebraska

Code:

NCT04222062

Conditions

Brain Tumor - Metastatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Carmustine 7.7Mg Wafer

Study Details

Brief 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.

Conditions

Brain Tumor - Metastatic

Study ID

NCT04222062

Start date

Nov 6, 2020

Status verified date

Apr, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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
  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard of Care Arm

The tumor will be removed surgically. Within 6 weeks after surgery, the resection will be treated with stereotactic radiosurgery (SRS).

experimental: GLIADEL Arm

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.

Interventions

Carmustine 7.7Mg Wafer

GLIADEL wafers will be placed to cover tumor bed immediately after tumor removal.

Primary outcome measure

  • Efficacy of GLIADEL compared to Stereotactic Radiosurgery (SRS) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Project Coordinator

402-559-0963IITOffice@unmc.edu

Taylor A Johnson, BS, MA

402-559-0963taylora.johnson@unmc.edu

Locations

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Michele R Aizenberg Ansari, MD

402-559-9614maizenberg@unmc.edu

More Information

Sponsor

University of Nebraska

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-04-28.