Using omental tissue to treat recurrent glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the safety of using laparoscopically harvested autologous omentum as a graft in patients undergoing resection for recurrent glioblastoma multiforme (GBM). The omental graft is hypothesized to enhance the delivery of chemotherapeutics and immune cells to the tumor site by circumventing the blood-brain barrier. The study will assess the feasibility and safety of this approach in a single-center, open-label format. The rich vascular supply of the omentum is expected to support healing and improve outcomes in patients with previously irradiated or infected surgical sites.

Why it matters

Who can join: the full rules

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 that in the opinion of the general surgeon makes removal of omentum more risky or inadequate.
10. Subject has severe renal insufficiency rendering gadolinium MRI contraindicated.
11. Subject who are unable to have an MRI scan for any reason.

Where it's running

• Lenox Hill Brain Tumor Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: John Boockvar, MD — Northwell Health
• Study coordinator: John Boockvar, MD
• Email: jboockvar@northwell.edu
• Phone: 212-434-3900

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.