Study on Increasing Light Dose in Photodynamic Therapy for Glioblastoma During Surgery

Sponsor: Hemerion Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05736406

Provider View

This clinical trial is testing the safety of using different light doses during surgery for patients with newly diagnosed glioblastoma, alongside standard chemotherapy treatment. The study involves both men and women aged 18 to 69.

Patient Parameters

Program Overview

The main goal of this study is to find out if using different doses of light during surgery is safe for patients with newly diagnosed glioblastoma, a type of brain cancer. This treatment is given in addition to the usual chemotherapy with temozolomide. The study will help plan future research by collecting important safety data. An independent board will review the safety information to decide if it's safe to increase the light dose.

Description

This study is a phase 1/2 trial, meaning it's in the early stages of testing. It takes place at one center and involves increasing the light dose in small groups of patients to find the highest dose that can be safely used. The light is used during surgery along with a special drug (5-ALA HCl) that helps target the cancer cells. If a patient experiences serious side effects related to the treatment, the dose will not be increased further. Serious side effects are those that are severe or require additional surgery. Patients will be monitored for side effects for 28 days after the procedure. After the light dose is determined, patients will continue with their regular care and will be checked at 6 months to see how their cancer is responding to the treatment.

Eligibility Criteria

Inclusion criteria

  1. 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.
  2. Signed informed consent which includes compliance with requirements and restrictions listed in the informed consent.
  3. Newly diagnosed GBM (grade IV malignant high-grade glioma), presumed on the basis of clinical and MRI criteria (intra-axial brain tumor with peripheral rim contrast enhancement)
  4. Karnofsky Performance Scale ≥ 70
  5. Eligible for surgery
  6. Amenable to maximal tumor resection based on MRI.
  7. Planned to receive SOC (i.e., Stupp Protocol) treatment after surgery.
  8. Ability to take oral medications.

Exclusion criteria

  1. Patients with radiographic tumors of/or involving unresectable midline, basal ganglia, or brain stem as assessed by MRI

  2. Patients with prior brain surgery other than stereotactic biopsy 2. Patient with Lynch syndrome 3. Patient with Li-Fraumeni syndrome 4. Debilitating cardiopulmonary disease, unstable Type 1 or Type 2 diabetes (treated or not) 5. History or current condition of another malignancy (excluding basal cell carcinoma, or carcinoma in-situ) unless treated and off all active therapy for more than 5 years 6. Clinically significant abnormal ECG results, including a corrected QT interval QTc > 480 ms 7. Creatinine clearance < 60 mL/min 8. Severe hepatic impairment (bilirubin > 1.5 x the upper limit of normal [ULN] or alkaline phosphatase or transaminases (AST, ALT) > 2.5 x ULN) 9. Known allergic reactions to silicone 10. Known allergic reactions or hypersensitivity to egg, soya, or peanut proteins.

    1. Febrile illness 12. Contraindication to 5-ALA HCl administration, including:

a. Porphyria b. 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, andtopical preparations containing ALA c. 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 13. Contraindication to MRI examination (e.g., MRI-incompatible pacemaker) 14. Treatment with another investigational drug or intervention within 30 days prior to or during the entire study 15. Predictable non-compliance with the rules for preventing the transient risk of skin photosensitization.

  1. Clinical follow up not possible for psychological, family, social, or geographic reasons.

  2. Legal incapacity 18. Pregnancy or lactation 19. Women of childbearing potential (WOCBP) and males with WOCBP partners not willing to use an effective contraceptive method from inclusion until end of study.

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