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Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma (DOSINDYGO)

Primary Purpose

Glioblastoma

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Gliolan
Intraoperative PDT
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Surgical indication of glioblastoma, Glioblastoma, Photodynamic Therapy, Neurosurgery, Oncology, 5-aminolevulinic Acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpital Erasme, Clinique Universitaire de Bruxelles
  • Hopital Roger Salengro, CHU LilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

intraoperative PDT 400J/cm²

intraoperative PDT 600J/cm²

intraoperative PDT 800J/cm²

Arm Description

Outcomes

Primary Outcome Measures

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

Progression Free Survival (PFS)
Number of patients without relapse within 25 mm of surgical site defined according to International RANO criteria
Global Progression Free Survival (PFS)
Median of progression-free survival time determined according to international RANO criteria
Overall Survival (OS)
Median of OS determined according to international RANO criteria
Response to treatment
Evaluated by MRI/ TEP 11C-MET every 3 months
Incidence of "intraoperative PDT" treatment-emergent Adverse Events
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
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)
Measuring the health-related quality of life in patients with brain cancer

Full Information

First Posted
May 12, 2020
Last Updated
January 17, 2023
Sponsor
University Hospital, Lille
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Hemerion Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT04391062
Brief Title
Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma
Acronym
DOSINDYGO
Official Title
A Multi-center Phase II Study With Light Dose Escalation During Intraoperative Photodynamic Therapy of Glioblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Hemerion Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
Surgical indication of glioblastoma, Glioblastoma, Photodynamic Therapy, Neurosurgery, Oncology, 5-aminolevulinic Acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intraoperative PDT 400J/cm²
Arm Type
Experimental
Arm Title
intraoperative PDT 600J/cm²
Arm Type
Experimental
Arm Title
intraoperative PDT 800J/cm²
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gliolan
Intervention Description
patient will receive 5-ALA 4 to 6 hours before surgery
Intervention Type
Device
Intervention Name(s)
Intraoperative PDT
Intervention Description
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 Outcome Measure Information:
Title
Maximum Tolerated Dose-Light Level (MTDL) defined as the light dose associated with an acceptable dose-limiting toxicity level (TDL)
Description
Dose level above which TDL is observed in more than 33% (i.e., d̀-> 2 of 6) of subjects in an arm
Time Frame
4 weeks (+/-3 days) post-PDT.
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
Number of patients without relapse within 25 mm of surgical site defined according to International RANO criteria
Time Frame
From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months
Title
Global Progression Free Survival (PFS)
Description
Median of progression-free survival time determined according to international RANO criteria
Time Frame
From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months
Title
Overall Survival (OS)
Description
Median of OS determined according to international RANO criteria
Time Frame
From the Date of diagnosis of glioblastoma until the death, an average 18 months
Title
Response to treatment
Description
Evaluated by MRI/ TEP 11C-MET every 3 months
Time Frame
every 3 months between the Date of intraoperative PDT until relapse/death, an average 18 months
Title
Incidence of "intraoperative PDT" treatment-emergent Adverse Events
Description
Collection of all Adverse events (AEs and SAEs) (according to NCI-CTCE V5.0) and reviewing by an Independent Safety Monitoring Board
Time Frame
From the beginning of treatment with intraoperative PDT up to relapsing/death, an average 18 months
Title
Quality of Life Questionnaire -C30 ( QLQ-C30
Description
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
Time Frame
Every 3 months from the signature of Consent form until relapse/death, an average 18 months
Title
Quality of Life Questionnaire - Brain Cancer Module (QLQ-BN20)
Description
Measuring the health-related quality of life in patients with brain cancer
Time Frame
Every 3 months from the signature of Consent form until relapse/death, an average 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Reyns, MD,PhD
Phone
+33320446721
Email
nicolas.reyns@chru-lille.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Maximilien Vermandel, MD
Email
clinical@hemerion.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Reyns, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Erasme, Clinique Universitaire de Bruxelles
City
Brussels
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence Lefranc, MD
Facility Name
Hopital Roger Salengro, CHU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962
First Name & Middle Initial & Last Name & Degree
Nicolas Reyns, MD,PhD

12. IPD Sharing Statement

Learn more about this trial

Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma

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