Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkp… (NCT03493932) | Clinical Trial Compass
CompletedPhase 1
Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade
United States21 participantsStarted 2018-09-24
Plain-language summary
Background:
Glioblastoma (GBM) brain tumors almost always return after treatment. When that happens the tumor can never completely be removed by surgery, so most people also receive drugs. Researchers want to see if combining the drugs nivolumab and BMS-986016 may help.
Objectives:
To study how nivolumab affects the brain s immune system in people who have had glioblastoma brain tumors return. To study how nivolumab and BMS-986016 affect brain tumors.
Eligibility:
Adults age 18 and older who have had a return of GBM
Design:
Participants will be screened with:
Medical history
Physical exam
Cheek swab
Heart, blood and urine tests
Chest x-ray
Magnetic resonance imaging (MRI) brain scan. Participants will lie on a table that slides in and out of a cylinder in a strong magnetic field. A contrast agent will be injected in an arm vein.
Participants will stay in the hospital. They will:
Have surgery. A tube will be inserted into the back. Brain tumor and bone marrow samples will be taken. Tubes will be inserted into the brain.
Have a computed tomography brain scan.
Stay in Intensive Care (ICU) 7 days. Fluid from the brain and back will be collected every few hours. In the ICU, participants will get nivolumab by IV for 30 minutes.
Have surgery to remove the tubes.
Have standard surgery to remove as much of the GBM as possible. Bone marrow will be removed.
After leaving the hospital, participants will have visits every 2 weeks to get the study drugs by IV and have physical exams and blood tests.
Participants will have a brain MRI once a month.
...
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Be 18 years of age or older.
✓. Have recurrent glioblastoma that is amenable to surgical resection.
✓. Agree to undergo brain surgery.
✓. Are eligible for 03-N-0164 "Evaluation and Treatment of Neurosurgical Disorders" protocol 5. Willing and able to appoint a durable power of attorney.
✓. Willing and able to appoint a durable power of attorney
✓. Are willing to use an effective method of contraception during the clinical study as defined on the consent and for 24 weeks (for women) or 33 weeks (for men) after the last dose of the study drug.
Exclusion criteria
✕. Have a bleeding disorder that cannot be corrected before invasive testing or surgery, or other medical conditions that would make surgery unsafe, such as lung or cardiac disease that would render them unable to tolerate the risk of general anesthesia, or severe immunodeficiency.
✕. Has a known additional malignancy that is progressing or requires active treatment within 3 years of registration. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
What they're measuring
1
Increase of Interferon Gamma Levels
Timeframe: Day 8
2
Microdialysis Catheter
Timeframe: Day 8
3
Drug Safety
Timeframe: Day 8
Trial details
NCT IDNCT03493932
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
✕. Are not able to lie on their back for up to 60 minutes
✕. Have primary CNS lymphoma.
✕. Has received systemic immunosuppressive treatments, aside from systemic corticosteroids (such as methotrexate, chloroquine, azathioprine, etc) within six months of registration