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NCT Number: NCT04391062

Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma

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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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Erasme, Clinique Universitaire de Bruxelles, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLIOLAN

Drug

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

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).

Primary outcomes

  1. Maximum Tolerated Dose-Light Level (MTDL) defined as the light dose associated with an acceptable dose-limiting toxicity level (TDL)

    Time frame: 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 outcomes

  1. Progression Free Survival (PFS)

    Time frame: 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

  2. Global Progression Free Survival (PFS)

    Time frame: 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

  3. Overall Survival (OS)

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

    Median of OS determined according to international RANO criteria

  4. Response to treatment

    Time frame: 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

  5. Incidence of "intraoperative PDT" treatment-emergent Adverse Events

    Time frame: 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

  6. Quality of Life Questionnaire -C30 ( QLQ-C30

    Time frame: 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

  7. Quality of Life Questionnaire - Brain Cancer Module (QLQ-BN20)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Hemerion Therapeutics
  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

A Multi-center Phase II Study With Light Dose Escalation During Intraoperative Photodynamic Therapy of Glioblastoma

Acronym: DOSINDYGO

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 18, 2020
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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