Safety Study of Laparoscopically Harvested Omental Tissue Graft During Surgery for Recurrent Glioblastoma Multiforme

What this Trial Is About

Researchers are evaluating the safety of using laparoscopically harvested autologous omental tissue implanted into the surgical cavity of patients with recurrent glioblastoma multiforme GBM, a type of brain cancer. This phase I, single-center, single-arm, open-label study explores whether this surgical technique, commonly used in head and neck cancer reconstruction, can bypass the blood-brain barrier and improve treatment delivery to the tumor site. The omental tissues rich blood vessels and immune cell content may enhance healing and immune response in the brain area after tumor removal. Participants will undergo standard surgical removal of recurrent GBM followed by implantation of a piece of omentum harvested laparoscopically from their abdomen into the brain tumor cavity. After the graft placement, the surgical site will be closed normally. The study focuses on monitoring the safety of this procedure and its effects on disease progression, seizures, stroke, infection, and survival outcomes. Participants will be closely monitored for side effects at multiple time points up to 180 days after the surgery, including MRI scans to assess disease progression. Safety assessments include tracking seizures, strokes, infections, and tumor growth. Secondary outcomes include progression-free survival and overall survival over six months. The study lasts up to 24 months to observe long-term effects and screen failure rates.

Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)