Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma
- Registration Number
- NCT04391062
- Lead Sponsor
- University Hospital, Lille
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 21
- 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
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Contraindications to 5-ALA (Gliolan®) and to intra-operative PhotoDynamic Therapy "intraoperative PDT":
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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
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Contraindications to surgery
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Contraindications to magnetic resonance imaging (MRI/TEP 11C MET
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Treatment with an experimental drug within 30 Days prior to the start of the study
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Clinical follow-up impossible to perform for psychological, familial, social or geographical reasons,
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Legal incapacity (persons deprived of their liberty or Guardianship or guardianship),
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Pregnant or nursing women
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Refusal to participate or sign the consent of the study
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Soy allergy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description intraoperative PDT 800J/cm² Gliolan - intraoperative PDT 400J/cm² Gliolan - intraoperative PDT 400J/cm² Intraoperative PDT - intraoperative PDT 600J/cm² Gliolan - intraoperative PDT 600J/cm² Intraoperative PDT - intraoperative PDT 800J/cm² Intraoperative PDT -
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose-Light Level (MTDL) defined as the light dose associated with an acceptable dose-limiting toxicity level (TDL) 4 weeks (+/-3 days) post-PDT. Dose level above which TDL is observed in more than 33% (i.e., d̀-\> 2 of 6) of subjects in an arm
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months Number of patients without relapse within 25 mm of surgical site defined according to International RANO criteria
Global Progression Free Survival (PFS) From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months Median of progression-free survival time determined according to international RANO criteria
Quality of Life Questionnaire -C30 ( QLQ-C30 Every 3 months from the signature of Consent form until relapse/death, an average 18 months The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items
Overall Survival (OS) From the Date of diagnosis of glioblastoma until the death, an average 18 months Median of OS determined according to international RANO criteria
Response to treatment every 3 months between the Date of intraoperative PDT until relapse/death, an average 18 months Evaluated by MRI/ TEP 11C-MET every 3 months
Quality of Life Questionnaire - Brain Cancer Module (QLQ-BN20) Every 3 months from the signature of Consent form until relapse/death, an average 18 months Measuring the health-related quality of life in patients with brain cancer
Incidence of "intraoperative PDT" treatment-emergent Adverse Events From the beginning of treatment with intraoperative PDT up to relapsing/death, an average 18 months Collection of all Adverse events (AEs and SAEs) (according to NCI-CTCE V5.0) and reviewing by an Independent Safety Monitoring Board
Trial Locations
- Locations (2)
Hôpital Erasme, Clinique Universitaire de Bruxelles
🇧🇪Brussels, Belgium
Hopital Roger Salengro, CHU Lille
🇫🇷Lille, France