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A Dose-escalation Clinical Study of Intraoperative Photodynamic Therapy of Glioblastoma

NCT05736406 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Primary Glioblastoma

Interventions

COMBINATION_PRODUCT

5-ALA HCl intraoperative Photodynamic Therapy (PDT) at 200 J/cm^2

5-ALA HCl, 20 mg/kg, is orally administered 4-6 hours before the surgery. Then after resection of tumor tissue is judged maximal, the intraoperative PDT procedure is initiated at 200 J/cm\^2.

COMBINATION_PRODUCT

5-ALA HCl intraoperative Photodynamic Therapy (PDT) at 400 J/cm^2

5-ALA HCl, 20 mg/kg, is orally administered 4-6 hours before the surgery. Then after resection of tumor tissue is judged maximal, the intraoperative PDT procedure is initiated at 400 J/cm\^2.

Sponsors & Collaborators

  • Hemerion Therapeutics

    lead INDUSTRY

Principal Investigators

  • Jan Drappatz, MD · UPMC Presbyterian Shadyside Hospital, Pittsburgh, PA

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-20
Primary Completion
2026-03-06
Completion
2026-08-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05736406 on ClinicalTrials.gov