GlioblastomaPhase 2DOSINDYGONCT04391062
Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma
A Phase 2 study testing Gliolan and Intraoperative PDT in people with Glioblastoma, run by University Hospital, Lille at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Gliolan and Intraoperative PDT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Sep 2021to 25 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Multi-center Phase II Study With Light Dose Escalation During 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.
- Conditions
- Glioblastoma
- Being tested
- Gliolan, Intraoperative PDT
- Keywords
- Surgical indication of glioblastoma, Glioblastoma, Photodynamic Therapy, Neurosurgery, Oncology, 5-aminolevulinic Acid
- Medical subject headings
- Glioblastoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GliolanDrug
patient will receive 5-ALA 4 to 6 hours before surgery
Intraoperative PDTDevice
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 group | Role | What they receive |
|---|---|---|
| intraoperative PDT 400J/cm² | Experimental | Not described Receives: Drug: Gliolan; Device: Intraoperative PDT |
| intraoperative PDT 600J/cm² | Experimental | Not described Receives: Drug: Gliolan; Device: Intraoperative PDT |
| intraoperative PDT 800J/cm² | Experimental | Not described Receives: Drug: Gliolan; Device: Intraoperative PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks (+/-3 days) post-PDT.
Secondary outcomes (7)
Progression Free Survival (PFS)
Number of patients without relapse within 25 mm of surgical site defined according to International RANO criteria
Measured: From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months
Global Progression Free Survival (PFS)
Median of progression-free survival time determined according to international RANO criteria
Measured: From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months
Overall Survival (OS)
Median of OS determined according to international RANO criteria
Measured: From the Date of diagnosis of glioblastoma until the death, an average 18 months
Response to treatment
Evaluated by MRI/ TEP 11C-MET every 3 months
Measured: every 3 months between the Date of intraoperative PDT until relapse/death, an average 18 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
Measured: From the beginning of treatment with intraoperative PDT up to relapsing/death, an average 18 months
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
Measured: Every 3 months from the signature of Consent form until relapse/death, an average 18 months
Quality of Life Questionnaire - Brain Cancer Module (QLQ-BN20)
Measuring the health-related quality of life in patients with brain cancer
Measured: Every 3 months from the signature of Consent form until relapse/death, an average 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start28 Sep 2021
- Primary completion25 Mar 2024
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Hemerion Therapeutics
- Responsible party
- Sponsor
- Investigators
- Nicolas Reyns, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391062
- Sponsor's protocol ID
- 2018_58
- Other IDs
- 2019-004796-40, 2019-A03157-50, 2019
- Acronym
- DOSINDYGO
- Status last verified
- Dec 2025
- First submitted
- 12 May 2020
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Phase II Study With Light Dose Escalation During Intraoperative Photodynamic Therapy of Glioblastoma
- ClinicalTrials.gov ID
- NCT04391062
- Acronym / sponsor ID
- DOSINDYGO / 2018_58
- Conditions
- Glioblastoma
- Keywords
- Surgical indication of glioblastoma, Glioblastoma, Photodynamic Therapy, Neurosurgery, Oncology, 5-aminolevulinic Acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Hemerion Therapeutics
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intraoperative PDT 400J/cm² | Experimental | Drug: Gliolan, Device: Intraoperative PDT |
| intraoperative PDT 600J/cm² | Experimental | Drug: Gliolan, Device: Intraoperative PDT |
| intraoperative PDT 800J/cm² | Experimental | Drug: Gliolan, Device: Intraoperative PDT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- Contraindications to 5-ALA (Gliolan®) and to intra-operative PhotoDynamic Therapy "intraoperative PDT":
- Contraindications to 5-ALA
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gliolanpatient will receive 5-ALA 4 to 6 hours before surgery | Drug | intraoperative PDT 400J/cm², intraoperative PDT 600J/cm², intraoperative PDT 800J/cm² |
| Intraoperative PDTThe 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). | Device | intraoperative PDT 400J/cm², intraoperative PDT 600J/cm², intraoperative PDT 800J/cm² |
Primary outcome
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
7 secondary outcomes
Progression Free Survival (PFS)
Time frame: From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months
Global Progression Free Survival (PFS)
Time frame: From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months
Overall Survival (OS)
Time frame: From the Date of diagnosis of glioblastoma until the death, an average 18 months
Response to treatment
Time frame: every 3 months between the Date of intraoperative PDT until relapse/death, an average 18 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Reyns, MD,PhD principal investigator
University Hospital, Lille
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gliolan and Intraoperative PDT in people with Glioblastoma, run by University Hospital, Lille at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.