OncoMatch/Clinical Trials/NCT05363826
Intracavitary Photodynamic Therapy as an Adjuvant to Resection of Glioblastoma or Gliosarcoma Using IV Photobac®
Is NCT05363826 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®) for glioblastoma multiforme of brain.
Treatment: photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Prior therapy
Must have received: radiation therapy — for glioblastoma or gliosarcoma
Subject has completed radiation therapy (RT) ... at least 30 days prior to entry
Must have received: alkylating agent (temozolomide) — for glioblastoma or gliosarcoma
Subject has completed ... temozolomide (TMZ) for the treatment of their glioblastoma or gliosarcoma at least 30 days prior to entry
Cannot have received: chemotherapy
Exception: in addition to radiation therapy and concomitant temozolomide within 30 days of planned PDT
Subject has received another chemotherapeutic or investigational agent in addition to radiation therapy and concomitant temozolomide treatment within 30 days of planned PDT
Cannot have received: investigational agent
Subject has received an investigational agent within 30 days prior to planned PDT
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Hemoglobin (Hgb) > 9.0 g/dL; WBC ≥ 4000; INR ≤ 1.1 x ULN
Kidney function
Creatinine clearance >60
Liver function
Plasma total bilirubin: ≤ 1.5 x ULN; ALT and AST ≤ 2.0 x ULN
Cardiac function
QTC interval ≤ 470 milliseconds (CTCAE grade 1) using Frederica's QT correction formula
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L Hemoglobin (Hgb) > 9.0 g/dL Plasma total bilirubin: ≤ 1.5 x ULN ALT and AST ≤ 2.0 x ULN Creatinine clearance >60 WBC ≥ 4000 INR ≤ 1.1 x ULN; QTC interval > 470 milliseconds (CTCAE grade 1) using Frederica's QT correction formula [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Roswell Park Cancer · Buffalo, New York
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