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

Launched by HEMERION THERAPEUTICS · Feb 17, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with primary glioblastoma, a serious type of brain tumor. The focus of the study is to see if using a special light therapy, called intraoperative photodynamic therapy (PDT), during surgery is safe and tolerable when added to the standard treatment, which includes chemotherapy. The trial is open to men and women aged 18 to 69 who have recently been diagnosed with glioblastoma and are eligible for surgery to remove the tumor.

Participants in this study will undergo surgery to remove as much of the tumor as possible, followed by the light therapy and standard chemotherapy. To ensure safety, an independent board will monitor the trial closely. Eligible individuals must be able to take oral medications and have a good performance status, meaning they can carry out daily activities. The study is currently recruiting patients, and those interested should speak with their doctor to see if they qualify.

Gender

ALL

Eligibility 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