Intraoperative light therapy for glioblastoma treatment
An Interventional, Multicenter, and International Phase 1/2, Light-dose-escalation Study to Investigate the Safety and Feasibility of Intraoperative Photodynamic Therapy (PDT) With Pentalafen® Drug and Heliance® Solution Device in Male and Female Patients 18 to 75 Years of Age With Grade IV Glioblastoma.
This study is testing if a special light therapy during surgery can safely help people with newly diagnosed glioblastoma feel better and live longer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hemerion Therapeutics Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Pittsburgh, Pennsylvania and 1 other locations) |
| Trial ID | NCT05736406 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and tolerability of two different doses of intraoperative photodynamic therapy (PDT) using 5-aminolevulinic acid hydrochloride (5-ALA HCl) in patients with newly diagnosed glioblastoma. The study follows a non-randomized, open-label, single-center design with a dose escalation approach to determine the maximal tolerated dose of light. Patients will undergo maximal surgical resection followed by PDT, and will be monitored for adverse events and progression-free survival over a six-month period. An independent Data and Safety Monitoring Board will oversee safety data to guide dose adjustments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with newly diagnosed glioblastoma who are eligible for surgery and planned to receive standard of care treatment.
Not a fit: Patients with unresectable tumors or those with certain genetic syndromes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with glioblastoma by enhancing tumor resection and reducing recurrence rates.
How similar studies have performed: While the approach of using photodynamic therapy in glioblastoma is being explored, this specific dose-escalation method is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria I01. Males or females must be between 18, or legal age of consent, and 75 years of age (both included) at the time of signing informed consent. I02. Signed informed consent which includes compliance with requirements and restrictions listed in the informed consent. I03. Newly diagnosed GBM, presumed on the basis of clinical and MRI criteria (intra-axial brain tumor with peripheral rim contrast enhancement). I04. Karnofsky Performance Score ≥70 I05. Eligible for surgery. I06. Amenable to maximal tumor resection based on MRI. I07. Planned to receive SOC (i.e., Stupp Protocol) treatment after surgery. I08. Ability to take oral medications. I09. Tumor eligible to PDT procedure as validated by both investigator and sponsor based on pre-operative MRI data Exclusion criteria 1.Medical conditions E01. 1. Patient with bifocal or multifocal disease, assessed on MR1I T1Gd enhanced. 2. Patient with tumor of deep location such as tumor involving the corpus callosum, the basal ganglia, the brain stem, or tumor involving the midline as assessed on MRI. 3. Patient with prior brain surgery other than stereotactic biopsy E02. Patient with Lynch syndrome E03. Patient with Li-Fraumeni syndrome E04. Debilitating cardiopulmonary disease, unstable Type 1 or Type 2 diabetes (treated or not) E05. History or current condition of another malignancy (excluding basal cell carcinoma, or E05. carcinoma in-situ) unless treated and off all active therapy for more than 5 years E06. Clinically significant abnormal ECG results, including a corrected QT interval QTc \> 480 ms E07. Creatinine clearance \< 60 mL/min E08. Severe hepatic impairment (bilirubin \> 1.5 x the upper limit of normal \[ULN\] or alkaline phosphatase or transaminases (AST, ALT) \> 2.5 x ULN) E09. Known allergic reactions to silicone E10. Known allergic reactions or hypersensitivity to egg, soya, or peanut proteins. E11. Febrile illness Contraindication E12. Contraindication to 5-ALA HCl administration, including: 1. Porphyria 2. Taking photosensitizing drugs 24 hours before and 14 days after the administration of Pentalafen® including but not limited to: St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines, and topical preparations containing ALA (See Section 6.10) 3. Inability to suspend a long-term hepatotoxic treatment (such as, but not limited to diclofenac, fenofibrate, carbamazepine) for 24 hours after 5-ALA HCl intake E13. Contraindication to MRI examination (e.g., MRI-incompatible pacemaker) E14. Treatment with another investigational drug or intervention within 30 days prior to or during the entire study
Where this trial is running
Pittsburgh, Pennsylvania and 1 other locations
- UPMC Hillman Cancer center — Pittsburgh, Pennsylvania, United States (Recruiting)
- CHU De Lille, Hôpital Roger Salengro — Lille, France (Recruiting)
Study contacts
- Principal investigator: Jan Drappatz, MD — UPMC Presbyterian Shadyside Hospital, Pittsburgh, PA
- Study coordinator: Antoine Mequignon, MSc
- Email: clinical@hemerion.com
- Phone: +33 6 62 78 94 01
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.