Clinical trial for Glioma
Official title Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)
ClinicalTrials.gov ID: NCT05979064
What this study is testing
- What it's testing
- The study aims to find out whether using a piece of the patient’s own omentum (abdominal tissue) is safe when implanted into the cavity left after removing a recurrent brain tumor.
- Who it's for
- Adults who have had a recurrent glioblastoma multiforme removed and are eligible for another surgery.
- What's involved
- During the operation, surgeons will laparoscopically (through small incisions) take a small piece of the patient’s omentum and implant it into the brain cavity. Participants will then have regular check‑ups and tests to monitor safety.
- Time commitment
- The study involves one surgery plus follow‑up visits over several months to assess safety.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Subject, if female, is pregnant or is breast feeding.
- Subject intends to participate in another clinical trial.
- 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.
See the full eligibility 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.
- 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.
- Subject has a histologically confirmed (frozen section) diagnosis of recurrent WHO Grade IV glioblastoma multiforme (GBM).
- Omental graft is technically feasible.
- Subject, if female, is pregnant or is breast feeding.
- Subject intends to participate in another clinical trial.
- 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.
- 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.
- Subject has had prior abdominal surgery that in the opinion of the general surgeon makes removal of omentum more risky or inadequate.
- Subject has severe renal insufficiency rendering gadolinium MRI contraindicated.
- Subject who are unable to have an MRI scan for any reason.
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.