A Multi-center Phase II Study With Light Dose Escalation During Intraoperative Photodynamic Therapy of Glioblastoma

Trial ID: NCT04391062

Interventional - Phase 2 - Completed

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

Interventions

• Gliolan
• Intraoperative PDT

Eligibility

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

Sponsor

University Hospital, Lille, Institut National de la Santé Et de la Recherche Médicale, France, Hemerion Therapeutics

Source: ClinicalTrials.gov

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