About this trial

This single center, single arm, open-label, phase I study will assess the safety of laparoscopically harvested autologous omentum, implanted into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Laparoscopically harvested omental tissue autograft

Treatment groups

10 Participants
are divided into 1 treatment group

Locations

1
Lenox Hill Brain Tumor Center10075, New YorkNew York, United States

Sponsors and collaborators

Northwell Health

Lead sponsor