Surgical Tissue Flap to Bypass the Blood Brain Barrier in GBM (NCT03630289) | Clinical Trial Compass
CompletedNot Applicable
Surgical Tissue Flap to Bypass the Blood Brain Barrier in GBM
United States12 participantsStarted 2018-07-27
Plain-language summary
This study assesses the safety of using tissue autograft of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multiforme (GBM) patients.
The objective of the study is to demonstrate that this surgical technique is safe in a small human cohort of patients with resected newly diagnosed GBM and may improve progression-free survival (PFS).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Absolute neutrophil count ≥ 1,500/µL
* Platelets ≥ 100,000/µL
* Hemoglobin \> 10.0 g/dL (transfusion and/or ESA allowed)
* Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x ULN
* Blood urea nitrogen (BUN) and creatinine \< 1.5 x ULN
* Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.
* Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner.
* Able to understand and willing to sign an institutional review board (IRB)-approved written informed consent document (legally authorized representative permitted).
Inclusion criteria considered during surgery:
* Subject has a histologically confirmed (frozen section) diagnosis of WHO Gra…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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