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Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04391062
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University Hospital, Lille
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Nicolas Reyns, MD,PhD
Principal Investigator Affiliation University Hospital, Lille
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Recruiting
Countries Belgium, France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Arms & Interventions

Arms

Experimental: intraoperative PDT 400J/cm²

Experimental: intraoperative PDT 600J/cm²

Experimental: intraoperative PDT 800J/cm²

Interventions

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Brussels, Belgium

Status

Not yet recruiting

Address

Hôpital Erasme, Clinique Universitaire de Bruxelles

Brussels, ,

Hopital Roger Salengro, CHU Lille, Lille, France

Status

Recruiting

Address

Hopital Roger Salengro, CHU Lille

Lille, , 59037

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