INtraoperative photoDYnamic Therapy of GliOblastoma

Study Overview
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Brief Summary
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The study pilot evaluate the feasibility of a 5-ALA- PpIX (protoporhyrin IX) mediated per-PDT protocol in patients with glioblastoma accessible for complete surgical removal of contrast. This treatment will be carried out in addition to the current reference treatment of glioblastoma: maximum resection surgery followed by radiochemotherapy according to the protocol Stupp

Official Title
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A Pilot Study of the Feasibility of Intraoperative Photodynamic Therapy of Glioblastoma.

Conditions
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Glioblastoma

Intervention / Treatment
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* Device: perPDT
* Drug: GLIOLAN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient male or female ≥18 years General status (WHO) of Performance status 0, 1 or 2 Probable glioblastoma according to clinical and radiological criteria, whose surgical indication was given in Multidisciplinary consultation meeting (RCP) of neurooncology, Decision to treat the patient as part of the Clinical trial also taken 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 scheduled at the hospital CHRU of Lille, center of reference of the region 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 Patient assigned to an heath insurance Exclusion Criteria: Contraindications to 5-ALA (Gliolan®) and to per-operative PhotoDynamic Therapy perPDT: 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) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: perPDT<br>Single arm : per-operative PhotoDynamic Therapy (perPDT) during the surgery of Glioblastoma excision. | Device: perPDT<br>* The protocol requires the realization of specific procedures in addition to the usual care. The per-operative photodynamic therapy (perPDT) added to surgery for glioblastoma excision. The patient will receive 5-ALA (5- alanine ,GLIOLAN drinkable) 4h before surgery + lighting of the tumor bed by a light source (laser) at the end of resection (Prolonged surgery of 45 minutes).<br>Drug: GLIOLAN<br>* patient will receive 5-ALA (5- alanine ,GLIOLAN drinkable) 4h before surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients having the full PerPDT treatment with unacceptable and unexpected toxicities (grade ≥ 3) graded According to NCI CTC Version 4.0 | In particular, the following complications will be investigated: severe infection, new neurological deficit responsible for severe disability, status epilepticus, deaths during the postoperative period. Target: At least 6/10 patients who benefited of complete PerPDT and without unacceptable and unexpected toxicities | From the intake of Gliolan (5-Ala) until 1 month post perPDT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) | Determined according to international RANO criteria | From the Date of diagnosis of glioblastoma until the date of Relapse defined, assessed up to 24 months | 
| Overall Survival (OS) | Determined according to international RANO criteria | From the date of Diagnosis of glioblastoma until the date of death, assessed up to 24 months | 
| Response to treatment | Evaluated by MRI every 3 months | From the date of perPDT until relapse/death, assessed up to 24 months | 
| Incidence of per PDT treatment-emergent Adverse Events | Collection of all Adverse events (AEs and SAEs) (according to NCI-CTC V4.0) and reviewing by an Independent Safety Monitoring Board. | From the beginning of treatment with perPDT up to relapsing/death, assessed up to 24 months | 
| Quality of Life Questionnaire -C30 ( QLQ-C30) | 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. | Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months | 
| Quality of Life Questionnaire - Brain Cancer Module (QLQ-BN20) | Measuring the health-related quality of life in patients with brain cancer | Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glioblastoma