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Carmustine Wafers for Brain Tumor

Phase 2
Recruiting
Research Sponsored by Michele Aizenberg, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older (Nebraska is 19 years or older)
RPA class I or II
Must not have
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
Prior whole brain radiation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

This trial is testing if adding GLIADEL to the site of a removed tumor, in addition to radiation treatment within six weeks of surgery, is more effective at preventing cancer recurrence than surgery and radiation alone.

Who is the study for?
This trial is for adults with certain types of solid cancer that has spread to the brain, who are planning surgery to remove one or two tumors. They should be in good physical condition (Karnofsky Score ≥ 70), not have had prior treatment on the area, and expect to live at least 3 more months. Pregnant women and those unable or unwilling to follow study rules can't join.
What is being tested?
The study compares adding GLIADEL wafers directly into the site after tumor removal versus just having radiation therapy post-surgery. The goal is to see which method better prevents cancer from returning.
What are the potential side effects?
GLIADEL may cause side effects like wound healing complications, seizures related to brain swelling, infection risk at the implant site, and potential damage to surrounding healthy brain tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 18 years old, or 19 if I live in Nebraska.
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My brain tumor condition is classified as mild or moderate.
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My platelet count is at least 100,000/mm3, transfusions are okay.
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I am able to care for myself but may not be able to do active work.
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I have up to 4 brain tumors from cancer spread, planning surgery for 1-2.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot stop my blood thinners or NSAIDs for surgery.
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I have had whole brain radiation therapy before.
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My tumor is larger than 4 cm.
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I have a condition like dementia affecting my brain.
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I have been diagnosed with lymphoma, germ cell cancer, small cell lung cancer, or anaplastic thyroid cancer.
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My brain cancer is classified as RPA class III.
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My cancer has spread to the lining of my brain and spinal cord.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy of GLIADEL compared to Stereotactic Radiosurgery (SRS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: GLIADEL ArmExperimental Treatment1 Intervention
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.
Group II: Standard of Care ArmActive Control1 Intervention
The tumor will be removed surgically. Within 6 weeks after surgery, the resection will be treated with stereotactic radiosurgery (SRS).

Find a Location

Who is running the clinical trial?

Michele Aizenberg, MDLead Sponsor
University of NebraskaLead Sponsor
554 Previous Clinical Trials
1,145,336 Total Patients Enrolled
Arbor Pharmaceuticals, Inc.Industry Sponsor
16 Previous Clinical Trials
2,215 Total Patients Enrolled

Media Library

Carmustine 7.7Mg Wafer Clinical Trial Eligibility Overview. Trial Name: NCT04222062 — Phase 2
Brain Tumor Research Study Groups: Standard of Care Arm, GLIADEL Arm
Brain Tumor Clinical Trial 2023: Carmustine 7.7Mg Wafer Highlights & Side Effects. Trial Name: NCT04222062 — Phase 2
Carmustine 7.7Mg Wafer 2023 Treatment Timeline for Medical Study. Trial Name: NCT04222062 — Phase 2
~23 spots leftby Dec 2025
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