RecruitingPhase 1NCT05363826

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


Sponsor

Photolitec LLC

Enrollment

30 participants

Start Date

Apr 11, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a light-based treatment (photodynamic therapy) delivered directly inside the skull after surgery to help destroy remaining glioblastoma or gliosarcoma cancer cells — aggressive brain tumors — that could not be fully removed during the operation. **You may be eligible if...** - You are 18 or older with a Karnofsky performance status of 70 or higher (able to care for yourself) - You have been confirmed by pathology to have glioblastoma or gliosarcoma - Your tumor has returned or progressed after standard treatment - Your doctor believes surgery can remove a meaningful portion of the tumor - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has not been treated previously - You have poor general health or are unable to undergo surgery - You have active uncontrolled infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTphotochemotherapy 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


Locations(1)

Roswell Park Cancer

Buffalo, New York, United States

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NCT05363826


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