Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Lille
• Collaborators: Hemerion Therapeutics; Institut National de la Santé Et de la Recherche Médicale, France

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