Glioblastoma
Conditions
Keywords
Surgical indication of glioblastoma, Glioblastoma, Photodynamic Therapy, Neurosurgery, Oncology, 5-aminolevulinic Acid
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.
Interventions
DRUGGliolan
patient will receive 5-ALA 4 to 6 hours before surgery
DEVICEIntraoperative PDT
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).
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Hemerion Therapeutics
University Hospital, Lille
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Belgium, France
Outcome results
None listed