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Trial record 1 of 1 for:    DOSINDYGO
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Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma (DOSINDYGO)

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ClinicalTrials.gov Identifier: NCT04391062
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : October 5, 2021
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Hemerion Therapeutics
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Gliolan Device: Intraoperative PDT Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center Phase II Study With Light Dose Escalation During Intraoperative Photodynamic Therapy of Glioblastoma
Actual Study Start Date : September 28, 2021
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: intraoperative PDT 400J/cm² Drug: Gliolan
patient will receive 5-ALA 4 to 6 hours before surgery

Device: Intraoperative 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).
Experimental: intraoperative PDT 600J/cm² Drug: Gliolan
patient will receive 5-ALA 4 to 6 hours before surgery

Device: Intraoperative 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).
Experimental: intraoperative PDT 800J/cm² Drug: Gliolan
patient will receive 5-ALA 4 to 6 hours before surgery

Device: Intraoperative 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).


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391062


Contacts
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Contact: Nicolas Reyns, MD,PhD +33320446721 nicolas.reyns@chru-lille.fr
Contact: Maximilien Vermandel, MD clinical@hemerion.com

Locations
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Belgium
Hôpital Erasme, Clinique Universitaire de Bruxelles Not yet recruiting
Brussels, Belgium
Principal Investigator: Florence Lefranc, MD         
France
Hopital Roger Salengro, CHU Lille Recruiting
Lille, France, 59037
Contact    0320445962      
Principal Investigator: Nicolas Reyns, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Institut National de la Santé Et de la Recherche Médicale, France
Hemerion Therapeutics
Investigators
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Principal Investigator: Nicolas Reyns, MD,PhD University Hospital, Lille
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04391062    
Other Study ID Numbers: 2018_58
2019-004796-40 ( EudraCT Number )
2019-A03157-50 ( Other Identifier: ID-RCB number, ANSM )
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Surgical indication of glioblastoma
Glioblastoma
Photodynamic Therapy
 Neurosurgery
Oncology
5-aminolevulinic Acid
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue