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A Study Comparing GLIADEL to Stereotactic Radiosurgery in Metastatic Brain Disease

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ClinicalTrials.gov Identifier: NCT04222062
Recruitment Status : Recruiting
First Posted : January 9, 2020
Last Update Posted : September 28, 2021
Sponsor:
Collaborator:
Arbor Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Michele Aizenberg, MD, University of Nebraska

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.

Condition or disease Intervention/treatment Phase
Brain Tumor - Metastatic Drug: Carmustine 7.7Mg Wafer Phase 2

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 subjects with one to four metastatic brain tumors with one tumor needing resection will be enrolled. Subjects 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.

Subjects 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.

Subjects will be evaluated pre-operatively with MRI brain and neuropsychological testing and will have immediate post-op MRI for extent of resection (EOR) determination. Subjects 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to either 1) the GLIADEL Arm or 2) the Standard of Care Arm (SRS post-op).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial Evaluating GLIADEL Compared to Stereotactic Radiosurgery in Subjects With Metastatic Brain Disease
Actual Study Start Date : November 6, 2020
Estimated Primary Completion Date : December 1, 2025
Estimated Study Completion Date : December 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Diseases
Drug Information available for: Carmustine

Arm Intervention/treatment
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.
Drug: Carmustine 7.7Mg Wafer
GLIADEL wafers will be placed to cover tumor bed immediately after tumor removal.
Other Name: GLIADEL




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years or older (Nebraska is 19 years or older)
  2. Karnofsky Performance Score ≥ 70
  3. RPA class I or II
  4. 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 only one.
  5. Adequate platelet count (≥ 100,000/mm3)
  6. Laboratory values adequate for patient to undergo surgery, including: (transfusion permitted to reach goals)

    1. Platelet count ≥ 100,000/mm3
    2. Absolute neutrophil count (ANC) ≥ 1,000/mm3
    3. Absolute lymphocyte count (ALC) ≥ 500/mm3
    4. Adequate liver function, including: Total bilirubin ≤ 1.5 x ULN (unless has Gilbert's syndrome) and ALT ≤ 2.5 x ULN
    5. Estimated glomerular filtration rate of at least 50 mL/min by the Cockcroft Gault formula
  7. Women of childbearing potential must have a negative pregnancy test within 7 days of initiating study
  8. INR ≤ 1.3
  9. Estimated survival time of ≥ 3 months as determined by the patient's primary oncologist.
  10. The subject is willing and able to consent to and abide by the protocol.

Exclusion Criteria:

  1. Prior treatment to the area of planned resection (surgery, radiation).
  2. Prior whole brain radiation therapy.
  3. Diagnosis of lymphoma, germ cell cancer, small cell lung cancer, anaplastic thyroid cancer.
  4. Leptomeningeal disease
  5. Neurodegenerative disorder (e.g. dementia).
  6. Tumor size > 4 cm.
  7. RPA class III
  8. Inability or unwillingness to co-operate with the requirements of the protocol
  9. 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.
  10. Participation in other therapeutic clinical trials
  11. Severe pulmonary, cardiac or other systemic disease, specifically:

    1. New York Heart Association > Grade 2 congestive heart failure within 6 months prior to study entry, unless asymptomatic and well controlled with medication
    2. Uncontrolled or significant cardiovascular disease, clinically significant ventricular arrhythmia, clinically significant pulmonary disease
  12. Subjects who have any other disease, either metabolic or psychological, which as per the Investigator assessment may affect the subject's compliance or place the subject at higher risk of potential treatment complications.
  13. The subject has a bleeding diathesis, or must take anticoagulants, or antiplatelet agents including NSAIDs (non-steroidal anti-inflammatory drugs), at the time of scheduled resection that cannot be stopped for surgery.
  14. Inability to obtain MRI studies.

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): NCT04222062


Contacts
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Contact: April Winchester 402-559-0963 april.winchester@unmc.edu
Contact: Peggy Heires 402-559-4596 peggy.heires@unmc.edu

Locations
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United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: April Winchester         
Sponsors and Collaborators
Michele Aizenberg, MD
Arbor Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Michele Aizenberg, MD University of Nebraska
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Responsible Party: Michele Aizenberg, MD, Professor of Neurosurgery, University of Nebraska
ClinicalTrials.gov Identifier: NCT04222062    
Other Study ID Numbers: 792-19
First Posted: January 9, 2020    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Carmustine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents