A Study Comparing GLIADEL to Stereotactic Radiosurgery in Metastatic Brain Disease

NCT04222062 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 0792-19-FB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months

Study Arms (2)

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.

Drug: Carmustine 7.7Mg Wafer

Interventions

Carmustine 7.7Mg Wafer DRUG

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

Also known as: GLIADEL

GLIADEL Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• Arbor Pharmaceuticals, Inc.: collaborator

Study Sites (2)

Henry Ford

Detroit, Michigan, 48202, United States

NOT YET RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Carmustine; carmustine, poliferprosan 20 drug combination

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds

Study Officials

• Michele Aizenberg, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Project Coordinator

CONTACT

402-559-0963; IITOffice@unmc.edu

Taylor A Johnson, BS, MA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to either 1) the GLIADEL Arm or 2) the Standard of Care Arm (SRS post-op).

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 9, 2020
• Study Start: November 6, 2020
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)