Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma

University Hospital, Lille14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioblastoma

Interventions

GliolanDRUG

patient will receive 5-ALA 4 to 6 hours before surgery

Intraoperative PDTDEVICE

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Hôpital Erasme, Clinique Universitaire de Bruxelles

Brussels, Belgium

Hopital Roger Salengro, CHU Lille

Lille, France

Outcomes

Primary Outcomes

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

Time frame: 4 weeks (+/-3 days) post-PDT.

Secondary Outcomes

Progression Free Survival (PFS)

Number of patients without relapse within 25 mm of surgical site defined according to International RANO criteria

Time frame: From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months

Global Progression Free Survival (PFS)

Median of progression-free survival time determined according to international RANO criteria

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: From the beginning of treatment with intraoperative PDT up to relapsing/death, an average 18 months

Data from ClinicalTrials.gov

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