Actively Recruiting
A Dose-escalation Clinical Study of Intraoperative Photodynamic Therapy of Glioblastoma
Led by Hemerion Therapeutics · Updated on 2025-09-11
12
Participants Needed
2
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Dose-escalation Clinical Study of Intraoperative Photodynamic Therapy of Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females between 18 and 75 years old at the time of informed consent
- Signed informed consent including agreement to study requirements and restrictions
- Newly diagnosed glioblastoma based on clinical and MRI criteria
- Karnofsky Performance Score of 70 or higher
- Eligible for surgery and planned for maximal tumor resection
- Planned to receive standard of care treatment (Stupp Protocol) after surgery
- Ability to take oral medications
- Tumor suitable for photodynamic therapy as confirmed by investigator and sponsor based on MRI
You will not qualify if you...
- Patients with bifocal or multifocal disease seen on MRI
- Tumors located deeply in the brain such as corpus callosum, basal ganglia, brain stem, or midline involvement
- Prior brain surgery other than stereotactic biopsy
- Patients with Lynch syndrome or Li-Fraumeni syndrome
- Debilitating cardiopulmonary disease or unstable diabetes
- History or current other malignancy unless treated and off therapy for more than 5 years
- Significant abnormal ECG including QTc > 480 ms
- Creatinine clearance below 60 mL/min
- Severe liver impairment (high bilirubin or liver enzymes)
- Known allergies to silicone, egg, soy, or peanut proteins
- Febrile illness
- Contraindications to 5-ALA HCl including porphyria, use of photosensitizing drugs near treatment time, or inability to suspend long-term hepatotoxic treatments
- Contraindications to MRI such as MRI-incompatible pacemaker
- Treatment with another investigational drug or intervention within 30 days prior or during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
UPMC Hillman Cancer center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
2
CHU De Lille, Hôpital Roger Salengro
Lille, France, 59037
Actively Recruiting
Research Team
A
Antoine Mequignon, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here