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Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma (DOSINDYGO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 12, 2020
First Posted Date  ICMJE May 18, 2020
Last Update Posted Date October 5, 2021
Actual Study Start Date  ICMJE September 28, 2021
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma
Official Title  ICMJE A Multi-center Phase II Study With Light Dose Escalation During Intraoperative Photodynamic Therapy of Glioblastoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • 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).

Study Arms  ICMJE
  • Experimental: intraoperative PDT 400J/cm²
    Interventions:
    • Drug: Gliolan
    • Device: Intraoperative PDT
  • Experimental: intraoperative PDT 600J/cm²
    Interventions:
    • Drug: Gliolan
    • Device: Intraoperative PDT
  • Experimental: intraoperative PDT 800J/cm²
    Interventions:
    • Drug: Gliolan
    • Device: Intraoperative PDT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 12, 2020)
21
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2024
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nicolas Reyns, MD,PhD +33320446721 nicolas.reyns@chru-lille.fr
Contact: Maximilien Vermandel, MD clinical@hemerion.com
Listed Location Countries  ICMJE Belgium,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04391062
Other Study ID Numbers  ICMJE 2018_58
2019-004796-40 ( EudraCT Number )
2019-A03157-50 ( Other Identifier: ID-RCB number, ANSM )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Hospital, Lille
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Lille
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Institut National de la Santé Et de la Recherche Médicale, France
  • Hemerion Therapeutics
Investigators  ICMJE
Principal Investigator: Nicolas Reyns, MD,PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP