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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.
Full description
This study is a non randomized, open label, multicentercenter , 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and 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.
E11. Febrile illness
Contraindication
E12. Contraindication to 5-ALA HCl administration, including:
Primary purpose
Allocation
Interventional model
Masking
12 participants in 2 patient groups
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Central trial contact
Antoine Mequignon, MSc
Data sourced from clinicaltrials.gov
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