Clinical trial NCT04391062: Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma
Official title: A Multi-center Phase II Study With Light Dose Escalation During Intraoperative Photodynamic Therapy of Glioblastoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Glioblastoma
Keywords: Surgical indication of glioblastoma
Glioblastoma
Photodynamic Therapy
Neurosurgery
Oncology
5-aminolevulinic Acid
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Hemerion Therapeutics
First posted: 2020-05-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Tolerated Dose-Light Level (MTDL) defined as the light dose associated with an acceptable dose-limiting toxicity level (TDL)
timeFrame: 4 weeks (+/-3 days) post-PDT.
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months
measure: Global Progression Free Survival (PFS)
timeFrame: From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months
measure: Overall Survival (OS)
timeFrame: From the Date of diagnosis of glioblastoma until the death, an average 18 months
measure: Response to treatment
timeFrame: every 3 months between the Date of intraoperative PDT until relapse/death, an average 18 months
measure: Incidence of "intraoperative PDT" treatment-emergent Adverse Events
timeFrame: From the beginning of treatment with intraoperative PDT up to relapsing/death, an average 18 months
measure: Quality of Life Questionnaire -C30 ( QLQ-C30
timeFrame: Every 3 months from the signature of Consent form until relapse/death, an average 18 months
measure: Quality of Life Questionnaire - Brain Cancer Module (QLQ-BN20)
timeFrame: Every 3 months from the signature of Consent form until relapse/death, an average 18 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Erasme, Clinique Universitaire de Bruxelles
city: Lille
country: France
facility: Hopital Roger Salengro, CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Nicolas Reyns, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: