OncoMatch/Clinical Trials/NCT05736406
A Dose-escalation Clinical Study of Intraoperative Photodynamic Therapy of Glioblastoma
Is NCT05736406 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including 5-ALA HCl intraoperative Photodynamic Therapy (PDT) at 200 J/cm^2 and 5-ALA HCl intraoperative Photodynamic Therapy (PDT) at 400 J/cm^2 for primary glioblastoma.
Treatment: 5-ALA HCl intraoperative Photodynamic Therapy (PDT) at 200 J/cm^2 · 5-ALA HCl intraoperative Photodynamic Therapy (PDT) at 400 J/cm^2 — The primary objective of this clinical trial is to determine the safety and tolerability of two doses of light in intraoperative PDT added to standard of care; temozolomide-based chemotherapy in male and female patients aged 18 to 75 with newly diagnosed glioblastoma. This treatment will be carried out in addition to the maximal surgical resection. Data collected during this trial will be used to design the upcoming pivotal study . The study will utilize an independent Data and Safety Monitoring Board (iDSMB) that will review safety data to allow dose escalation.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Prior therapy
Cannot have received: brain surgery
Exception: stereotactic biopsy
Patient with prior brain surgery other than stereotactic biopsy
Cannot have received: investigational drug or intervention
Treatment with another investigational drug or intervention within 30 days prior to or during the entire study
Lab requirements
Kidney function
creatinine clearance < 60 mL/min [excluded]
Liver function
bilirubin > 1.5 x ULN or alkaline phosphatase or transaminases (AST, ALT) > 2.5 x ULN [excluded]
Cardiac function
clinically significant abnormal ECG results, including a corrected QT interval QTc > 480 ms [excluded]
Creatinine clearance < 60 mL/min [excluded]. Severe hepatic impairment (bilirubin > 1.5 x ULN or alkaline phosphatase or transaminases (AST, ALT) > 2.5 x ULN) [excluded]. Clinically significant abnormal ECG results, including a corrected QT interval QTc > 480 ms [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UPMC Hillman Cancer center · Pittsburgh, Pennsylvania
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