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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004796-40 | EudraCT Number | ||
| 2019-A03157-50 | Other Identifier | ID-RCB number, ANSM |
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| Hemerion Therapeutics | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intraoperative PDT 400J/cm² | Experimental |
| |
| intraoperative PDT 600J/cm² | Experimental |
| |
| intraoperative PDT 800J/cm² | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gliolan | Drug | patient will receive 5-ALA 4 to 6 hours before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose-Light Level (MTDL) defined as the light dose associated with an acceptable dose-limiting toxicity level (TDL) | Dose level above which TDL is observed in more than 33% (i.e., d̀-> 2 of 6) of subjects in an arm | 4 weeks (+/-3 days) post-PDT. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Number of patients without relapse within 25 mm of surgical site defined according to International RANO criteria | From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months |
| Global Progression Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications to 5-ALA (Gliolan®) and to intra-operative PhotoDynamic Therapy "intraoperative PDT":
Contraindications to 5-ALA
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
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Reyns, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Erasme, Clinique Universitaire de Bruxelles | Brussels | Belgium | ||||
| Hopital Roger Salengro, CHU Lille |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| Intraoperative PDT | Device | The protocol requires the realization of specific procedures in addition to the usual care. The intra-operative photodynamic therapy ("intraoperative PDT") added to surgery for glioblastoma excision. The patient will receive 5-ALA ( 5-aminolevulinic acid hydrochloride),GLIOLAN drinkable 6h before surgery + lighting of the tumor bed by a red light source (laser with different J/cm²) at the end of resection (Prolonged surgery of 45 minutes). |
|
Median of progression-free survival time determined according to international RANO criteria |
| From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months |
| Overall Survival (OS) | Median of OS determined according to international RANO criteria | From the Date of diagnosis of glioblastoma until the death, an average 18 months |
| Response to treatment | Evaluated by MRI/ TEP 11C-MET every 3 months | every 3 months between the Date of intraoperative PDT until relapse/death, an average 18 months |
| Incidence of "intraoperative PDT" treatment-emergent Adverse Events | Collection of all Adverse events (AEs and SAEs) (according to NCI-CTCE V5.0) and reviewing by an Independent Safety Monitoring Board | From the beginning of treatment with intraoperative PDT up to relapsing/death, an average 18 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, an average 18 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, an average 18 months |
| Lille |
| 59037 |
| France |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |