Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma

NCT ID: NCT04391062

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2024-03-25

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intraoperative PDT 400J/cm²

Group Type: EXPERIMENTAL

Gliolan

Intervention Type: DRUG

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

Intraoperative PDT

Intervention Type: 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 600J/cm²

Group Type: EXPERIMENTAL

Gliolan

Intervention Type: DRUG

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

Intraoperative PDT

Intervention Type: 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 800J/cm²

Group Type: EXPERIMENTAL

Gliolan

Intervention Type: DRUG

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

Intraoperative PDT

Intervention Type: 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).

Interventions

Gliolan

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

Intervention Type: DRUG

Intraoperative PDT

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Soy allergy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Hemerion Therapeutics

INDUSTRY

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas Reyns, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hôpital Erasme, Clinique Universitaire de Bruxelles

Brussels, , Belgium

Hopital Roger Salengro, CHU Lille

Lille, , France

Countries

Belgium; France

Other Identifiers

2019-004796-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2019-A03157-50

Identifier Type: OTHER

Identifier Source: secondary_id

2018_58

Identifier Type: -

Identifier Source: org_study_id