Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma

Glioblastoma Clinical Trial

— DOSINDYGO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04391062
• Other study ID #: 2018_58
• Secondary ID: 2019-004796-4020
• Status: Recruiting
• Phase: Phase 2
• Start date: September 28, 2021
• Est. completion date: September 2025

Study information

• Verified date: January 2023
• Source: University Hospital, Lille
• Contact: Nicolas Reyns, MD,PhD
• Phone: +33320446721
• Email: nicolas.reyns[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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).

Locations

Country	Name	City	State
Belgium	Hôpital Erasme, Clinique Universitaire de Bruxelles	Brussels
France	Hopital Roger Salengro, CHU Lille	Lille

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	Hemerion Therapeutics, Institut National de la Santé Et de la Recherche Médicale, France

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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., d`-> 2 of 6) of subjects in an arm	4 weeks (+/-3 days) post-PDT.
Secondary	Progression Free Survival (PFS)	Number of patients without relapse within 25 mm of surgical site defined according to International RANO criteria	From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months
Secondary	Global Progression Free Survival (PFS)	Median of progression-free survival time determined according to international RANO criteria	From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months
Secondary	Overall Survival (OS)	Median of OS determined according to international RANO criteria	From the Date of diagnosis of glioblastoma until the death, an average 18 months
Secondary	Response to treatment	Evaluated by MRI/ TEP 11C-MET every 3 months	every 3 months between the Date of intraoperative PDT until relapse/death, an average 18 months
Secondary	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	From the beginning of treatment with intraoperative PDT up to relapsing/death, an average 18 months
Secondary	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	Every 3 months from the signature of Consent form until relapse/death, an average 18 months
Secondary	Quality of Life Questionnaire - Brain Cancer Module (QLQ-BN20)	Measuring the health-related quality of life in patients with brain cancer	Every 3 months from the signature of Consent form until relapse/death, an average 18 months