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

Study Purpose

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 69 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 69 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion criteria. 1. Males or females must be between 18, or legal age of consent, and 69 years of age (inclusive) 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 ≥ 60. 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. Patient with Lynch syndrome. 3. Patient with Li-Fraumeni syndrome. 4. Debilitating cardiopulmonary disease. 5. Any history of cancer. 6. Clinically significant abnormal ECG results, including a corrected QT interval QtCf > 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. 11. Febrile illness. 12. Contraindication to 5-ALA HCl administration, including: 1. Porphyria. 2. Taking photosensitizing drugs 24 hours before administration of Pentalafen® 3. Inability to suspend a long-term hepatotoxic treatment for 24 hours after 5-ALA HCl intake. 13. Contraindication to MRI examination (e.g., pacemaker or metallic foreign body) 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. 16. Clinical follow up not possible for psychological, family, social, or geographic reasons. 17. Legal incapacity. 18. Pregnancy or lactation Women of childbearing potential (WOCBP) and males with WOCBP partners not willing to use an effective contraceptive method from inclusion until end of study

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05736406
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hemerion Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jan Drappatz, MD
Principal Investigator Affiliation UPMC Presbyterian Shadyside Hospital, Pittsburgh, PA
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Primary Glioblastoma
Additional Details

This study is a non randomized, open label, single center , phase 1/2 trial with a sequential enrollment in a 3+3 dose escalation design to establish the maximal tolerated dose of light (MTD). The dose of light will be escalated in successive cohorts of patients until at least 1 patient experiences a dose-limiting toxicity (DLT). A DLT is defined as any grade ≥ 3 Adverse Event (AE), or any relevant grade 2 AE of Central Nervous System or any Serious Adverse Events (SAEs) possibly, probably or definitively related to the intraoperative PDT (i.e., 5-aminolevulinic acid hydrochloride (5-ALA HCl) administration + brain cavity illumination), for which the onset date is within 28 days after the procedure, and where conservative therapy fails and surgical is required, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. After dose escalation patient will be followed in the standard of care until visit at 6 months to evaluate the progression free survival.

Arms & Interventions

Arms

Experimental: 200 J/cm^2

Patient will undergo intraoperative Photodynamic therapy at 200 J/cm^2

Experimental: 400 J/cm^2

Patient will undergo intraoperative Photodynamic therapy at 400 J/cm^2

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UPMC Hillman Cancer center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

UPMC Hillman Cancer center

Pittsburgh, Pennsylvania, 15213

Site Contact

Jan Drappatz

clinical@hemerion.com

+33 6 62 78 94 01