Status:
COMPLETED
Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Hemerion Therapeutics
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 enha...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04391062
Start Date
September 28 2021
End Date
March 25 2024
Last Update
December 5 2025
Active Locations (2)
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1
Hôpital Erasme, Clinique Universitaire de Bruxelles
Brussels, Belgium
2
Hopital Roger Salengro, CHU Lille
Lille, France, 59037