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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
No Placebo-Only Group
All Individual Drugs Already Approved
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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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
555 Previous Clinical Trials
1,145,262 Total Patients Enrolled
Arbor Pharmaceuticals, Inc.Industry Sponsor
16 Previous Clinical Trials
2,215 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood's ability to clot is within a certain range.I am at least 18 years old, or 19 if I live in Nebraska.You cannot have an MRI scan.My brain tumor condition is classified as mild or moderate.My platelet count is at least 100,000/mm3, transfusions are okay.I cannot stop my blood thinners or NSAIDs for surgery.You are already taking part in another medical research study.I am able to care for myself but may not be able to do active work.I have up to 4 brain tumors from cancer spread, planning surgery for 1-2.Your doctor expects you to live for at least 3 more months.I have had whole brain radiation therapy before.My tumor is larger than 4 cm.I have a condition like dementia affecting my brain.I have been diagnosed with lymphoma, germ cell cancer, small cell lung cancer, or anaplastic thyroid cancer.I have had previous treatments like surgery or radiation on the area to be operated on.My blood tests are good enough for surgery, and I can receive blood if needed.I have taken a pregnancy test in the last week and it was negative.My brain cancer is classified as RPA class III.My cancer has spread to the lining of my brain and spinal cord.I do not have severe heart, lung, or other serious health issues that could affect my treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care Arm
- Group 2: GLIADEL Arm
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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