NCT05363826

Intracavitary Photodynamic Therapy as an Adjuvant to Resection of Glioblastoma or Gliosarcoma Using IV Photobac®

Phase I Study of the Safety of Intracavitary Photodynamic Therapy (PDT) of the Brain Bordering Resected Recurrent Glioblastoma or Gliosarcoma Using Intravenous Photobac® and a Balloon Light Applicator

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Photolitec LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is the first step in testing the hypothesis that adding Photobac® Photodynamic Therapy to surgical removal of a glioblastoma or gliosarcoma will be both safe and effective. Photodynamic Therapy (PDT) combines light and a photosensitizer. PDT has been used to treat a variety of cancers with varying degrees of success. For the past thirty years Photolitec has been working to develop a treatment for glioblastoma or gliosarcoma using light and a photosensitizer. Photolitec's scientists were looking for a photosensitizer that: 1. has no significant systemic toxicity apart from some temporary skin photosensitivity, 2. crosses the blood brain barrier, 3. accumulates to a high level in glioblastoma and minimally in the brain, 4. is activated by the wavelength of light that penetrates most deeply into the brain, 5. minimizes any temporary skin photosensitivity. Preliminary testing indicates the Photolitec team has achieved these five goals. Photolitec is now able to offer a clinical trial based on the results of this work.

Detailed description

Twenty four hours before surgery the patient will receive an intravenous injection of Photobac®. This will make the brain tumor sensitive to light. Lighting up the brain using a low power near infrared laser will kill cells that contain Photobac®. Photobac® crosses the blood brain barrier. Compared to the brain at 24 hours after injection, the tumor holds significantly more Photobac®. This Selective retention by tumors is the reason PDT has proved a valuable weapon against other types of tumors. Once the surgeon has removed the tumor as completely as possible, the brain that bordered the tumor will be illuminated with near infrared light from a low power laser. This will destroy tumor cells hiding deep in the brain. Such cells cause tumor recurrence. The light treatment will add about one hour to the surgery. The Patient will be asleep during this procedure. The patient will receive standard post-surgical care during recovery.

Conditions

• Glioblastoma Multiforme of Brain
• Glioma, Sarcomatous

Interventions

Type	Name	Description
COMBINATION_PRODUCT	photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®)	Intravenous injection of Photobac® 24 hours before surgical removal of recurrent GBMF. Immediately after resection, the cavity will be treated with 50 joules/ square cm of 787nm light. This treatment will add a maximum of 50 minutes to the surgery

Timeline

• Start date: 2023-04-11
• Primary completion: 2025-05-01
• Completion: 2026-05-01
• First posted: 2022-05-06
• Last updated: 2023-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study