Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma

NCT04391062 | Completed Phase 2 DMC

• 3 other identifiers: 2018_582019-004796-402019-A03157-50
• Study Type: interventional
• Target: 14
• Locations: 2 countries
• Sites: 2

Brief Summary

The phase II study evaluate a light dose escalation in a classical intraoperative PDT regimen mediated by 5-ALA-PpIX, in glioblastoma patients with access to full surgical removal of the contrast enhancement. This treatment will be performed in addition to the current reference treatment of glioblastoma: maximum removal surgery followed by radiochemotherapy according to the Stupp protocol.

Conditions

Glioblastoma

Keywords

Surgical indication of glioblastoma; Glioblastoma; Photodynamic Therapy; Neurosurgery; Oncology; 5-aminolevulinic Acid

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose-Light Level (MTDL) defined as the light dose associated with an acceptable dose-limiting toxicity level (TDL)

  Dose level above which TDL is observed in more than 33% (i.e., d̀-\> 2 of 6) of subjects in an arm

  4 weeks (+/-3 days) post-PDT.

Secondary Outcomes (7)

• Progression Free Survival (PFS)

  From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months

• Global Progression Free Survival (PFS)

  From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months

• Overall Survival (OS)

  From the Date of diagnosis of glioblastoma until the death, an average 18 months

• Response to treatment

  every 3 months between the Date of intraoperative PDT until relapse/death, an average 18 months

• Incidence of "intraoperative PDT" treatment-emergent Adverse Events

  From the beginning of treatment with intraoperative PDT up to relapsing/death, an average 18 months

Study Arms (3)

intraoperative PDT 400J/cm²

EXPERIMENTAL

Drug: Gliolan; Device: Intraoperative PDT

intraoperative PDT 600J/cm²

EXPERIMENTAL

Drug: Gliolan; Device: Intraoperative PDT

intraoperative PDT 800J/cm²

EXPERIMENTAL

Drug: Gliolan; Device: Intraoperative PDT

Interventions

Gliolan DRUG

patient will receive 5-ALA 4 to 6 hours before surgery

intraoperative PDT 400J/cm²; intraoperative PDT 600J/cm²; intraoperative PDT 800J/cm²

Intraoperative PDT DEVICE

The protocol requires the realization of specific procedures in addition to the usual care. The intra-operative photodynamic therapy ("intraoperative PDT") added to surgery for glioblastoma excision. The patient will receive 5-ALA ( 5-aminolevulinic acid hydrochloride),GLIOLAN drinkable 6h before surgery + lighting of the tumor bed by a red light source (laser with different J/cm²) at the end of resection (Prolonged surgery of 45 minutes).

intraoperative PDT 400J/cm²; intraoperative PDT 600J/cm²; intraoperative PDT 800J/cm²

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General status (WHO) Karnofsky Performance Status ≥60
• Presumptive glioblastoma according to radiological criteria,
• Surgical indication decided in Multidisciplinary consultation meeting (RCP) of neuro oncology,
• Decision to treat the patient as part of the Clinical trial achieved in neuro-oncology RCP ("Multidisciplinary consultation meeting")
• Patient operable on the basis of absence of cardiopulmonary disease history; a complete medical check-up sufficient to insure a post-operative state with normal daily life
• Clinical neuro-oncological monitoring and long-term MRI/ TEP 11C MET scheduled at the hospital centers
• Patient able to understand and sign voluntarily Informed consent
• Patient able to adhere to the visit's calendar of the study and other imperatives of the protocol
• Women of child-bearing potential should benefit of an effective contraception
• For patients receiving hepatotoxic therapy in the long term, this treatment must be suspended during the 24h after taking 5-ALA

You may not qualify if:

• Contraindications to 5-ALA (Gliolan®) and to intra-operative PhotoDynamic Therapy "intraoperative PDT":
• Contraindications to 5-ALA
• Porphyria
• Taking photosensitizer treatment
• Severe renal or hepatic impairment
• Bilirubin\> 1.5 x maximum level, Alkaline Phosphatases and transaminases (ASAT)\> 2.5 x Maximum. rates
• Creatinine clearance \<30 mL / min;
• Non-compliance with the rules of prevention of the transient risk of cutaneous photosensitization
• Contraindications to surgery
• Contraindications to magnetic resonance imaging (MRI/TEP 11C MET
• Treatment with an experimental drug within 30 Days prior to the start of the study
• Clinical follow-up impossible to perform for psychological, familial, social or geographical reasons,
• Legal incapacity (persons deprived of their liberty or Guardianship or guardianship),
• Pregnant or nursing women
• Refusal to participate or sign the consent of the study

Sponsors & Collaborators

• University Hospital, Lille: lead
• Hemerion Therapeutics: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (2)

Hôpital Erasme, Clinique Universitaire de Bruxelles

Brussels, Belgium

Location

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Glioblastoma; Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Nicolas Reyns, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 18, 2020
• Study Start: September 28, 2021
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

BE (1); FR (1)