Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)

Launched by NORTHWELL HEALTH · Jul 31, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with recurrent glioblastoma multiforme (GBM), which is a type of aggressive brain cancer. The study will look at the safety of using a piece of tissue called the omentum, which is taken from the abdomen during surgery, and then placed into the area where the tumor was removed. This study aims to see if this method can help improve outcomes for patients who have had their cancer come back after initial treatment.

To be eligible for the trial, participants must be at least 18 years old and scheduled for surgery to remove a known or suspected GBM. They should be in reasonably good health, with a specific score that indicates they can carry out daily activities. Other important factors include having a life expectancy of at least six months and being able to undergo MRI scans. Participants will have the surgery and the omentum will be implanted, after which the study will monitor their recovery and any side effects. It's essential that potential participants understand the study's requirements and are willing to provide informed consent before joining.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is a male or female 18 years of age or older.
• • 2. Subject is undergoing planned resection of known or suspected GBM.
• • 3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.
• • 4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.
• • 5. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.
• • 6. Subject must be able to undergo MRI evaluation.
• 7. Subject meets the following laboratory criteria:
• • 1. White blood count ≥ 3,000/μL
• • 2. Absolute neutrophil count ≥ 1,500/μL
• • 3. Platelets ≥ 100,000/μL
• • 4. Hemoglobin \> 10.0 g/dL (transfusion and/or ESA allowed)
• • 5. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)
• • 6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x ULN
• • 7. Blood urea nitrogen (BUN) and creatinine \< 1.5 x ULN
• • 8. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.
• • 9. Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document
• Inclusion criteria considered during surgery:
• • 1. Subject has a histologically confirmed (frozen section) diagnosis of recurrent WHO Grade IV glioblastoma multiforme (GBM).
• • 2. Omental graft is technically feasible.
• Exclusion Criteria:
• • 1. Subject, if female, is pregnant or is breast feeding.
• • 2. Subject intends to participate in another clinical trial.
• • 3. Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.
• • 4. Subject has an active infection requiring treatment.
• • 5. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.
• • 6. 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
• • 7. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.
• • 8. 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.
• • 9. Subject has had prior abdominal surgery.
• • 10. Subject has severe renal insufficiency rendering gadolinium MRI contraindicated.
• • 11. Subject who are unable to have an MRI scan for any reason.