Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma (DOSINDYGO)

University Hospital, Lille

Status and phase: Completed; Phase 2

Conditions: Glioblastoma

Treatments: Drug: Gliolan; Device: Intraoperative PDT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04391062

2019-A03157-50 (Other Identifier)

2019-004796-40 (EudraCT Number)

2018_58

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

14 participants in 3 patient groups

intraoperative PDT 400J/cm²

Experimental group

Treatment:

Device: Intraoperative PDT

Drug: Gliolan

intraoperative PDT 600J/cm²

Experimental group

Treatment:

Device: Intraoperative PDT

Drug: Gliolan

intraoperative PDT 800J/cm²

Experimental group

Treatment:

Device: Intraoperative PDT

Drug: Gliolan