Omental Tissue Autograft for Brain Tumor

N/A

Recruiting

Led By John Boockvar, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if it's safe to use a patient's own omentum to treat recurrent GBM tumors after surgery.

Who is the study for?

This trial is for adults over 18 with recurrent Grade IV glioblastoma multiforme (GBM) who are candidates for significant tumor resection and can undergo MRI scans. They must have a life expectancy of at least 6 months, meet specific lab criteria, and not be pregnant or breastfeeding. Exclusions include active infections, other clinical trials participation, prior abdominal surgery, or severe renal issues.

What is being tested?

The study tests the safety of implanting laparoscopically harvested autologous omentum tissue into the cavity after GBM tumor resection. It's an early-phase trial to see if this approach is safe in patients with recurrent brain tumors.

What are the potential side effects?

While specific side effects aren't listed here, potential risks may include complications from laparoscopic surgery such as infection or bleeding, reaction to anesthesia, and any unforeseen impacts of introducing omental tissue into the brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety parameter: proportion of patients experiencing increase in seizures, stroke, and infection.

Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria harvested omental graft for recurrent glioblastoma multiforme (rGBM).

Secondary study objectives

Overall Survival (OS)

Percent of screen fails

Progression Free Survival (PFS)