Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) … (NCT04222309) | Clinical Trial Compass
SuspendedPhase 1
Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)
Stopped: Per IRB closed and opened a new study.
United States10 participantsStarted 2020-01-06
Plain-language summary
This single center, single arm, open-label, phase I study will assess the safety of a laparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.
All participants included in the study will undergo standard surgical resection for diagnosed recurrent GBM. Following the resection, the surgical cavity will be lined with a laparoscopically harvested omental free flap. The participant's dura, bone and scalp will be closed as is customary. The participant will be followed for side effects within 72 hours, 7 days, 30 days, 90 days and 180 days. Risk assessment will include seizure, stroke, infection, tumor progression, and death.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject is a male or female 18 years of age or older.
✓. Subject is undergoing planned resection of known or suspected GBM.
✓. Subject has a Karnofsky Performance Status (KPS) 70% or greater.
✓. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.
✓. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.
✓. Subject must be able to undergo MRI evaluation.
✓. Subject meets the following laboratory criteria:
✓. White blood count ≥ 3,000/µL
Exclusion criteria
✕. Subject, if female, is pregnant or is breast feeding.
✕. Subject intends to participate in another clinical trial.
What they're measuring
1
Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria
Timeframe: Study Day 1-180
2
Safety parameter: proportion of patients experiencing increase in seizures, stroke, and infection
. Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.
✕. Subject has an active infection requiring treatment.
✕. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.
✕. Subject has a history of other malignancy, unless the patient has been disease-free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment
✕. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.
✕. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.