Clinical trial NCT03048240: INtraoperative photoDYnamic Therapy of GliOblastoma
Official title: A Pilot Study of the Feasibility of Intraoperative Photodynamic Therapy of Glioblastoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioblastoma
Keywords: Glioblastoma
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2017-02-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study pilot evaluate the feasibility of a "5-ALA- PpIX (protoporhyrin IX) mediated per-PDT protocol" in patients with glioblastoma accessible for complete surgical removal of contrast. This treatment will be carried out in addition to the current reference treatment of glioblastoma: maximum resection surgery followed by radiochemotherapy according to the protocol Stupp


Eligibility criteria: Inclusion Criteria:

1. Patient male or female ≥18 years
2. General status (WHO) of Performance status 0, 1 or 2
3. Probable glioblastoma according to clinical and radiological criteria,
4. whose surgical indication was given in Multidisciplinary consultation meeting (RCP) of neurooncology,
5. Decision to treat the patient as part of the Clinical trial also taken in neuro-oncology RCP ("Multidisciplinary consultation meeting")
6. 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
7. Clinical neuro-oncological monitoring and long-term MRI scheduled at the hospital CHRU of Lille, center of reference of the region
8. Patient able to understand and sign voluntarily Informed consent
9. Patient able to adhere to the visit's calendar of the study and other imperatives of the protocol
10. Women of child-bearing potential should benefit of an effective contraception
11. For patients receiving hepatotoxic therapy in the long term, this treatment must be suspended during the 24h after taking 5-ALA
12. Patient assigned to an heath insurance

Exclusion Criteria:

1. Contraindications to 5-ALA (Gliolan®) and to per-operative PhotoDynamic Therapy "perPDT":
2. 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
3. Contraindications to surgery
4. Contraindications to magnetic resonance imaging (MRI)
5. Treatment with an experimental drug within 30 Days prior to the start of the study
6. Clinical follow-up impossible to perform for psychological, familial, social or geographical reasons,
7. Legal incapacity (persons deprived of their liberty or Guardianship or guardianship),
8. Pregnant or nursing women
9. Refusal to participate or sign the consent of the study
10. Soy allergy

Primary outcomes:
measure: Number of Patients having the full "PerPDT" treatment with unacceptable and unexpected toxicities (grade ≥ 3) graded According to NCI CTC Version 4.0
timeFrame: From the intake of Gliolan (5-Ala) until 1 month post "perPDT"
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From the Date of diagnosis of glioblastoma until the date of Relapse defined, assessed up to 24 months
measure: Overall Survival (OS)
timeFrame: From the date of Diagnosis of glioblastoma until the date of death, assessed up to 24 months
measure: Response to treatment
timeFrame: From the date of perPDT until relapse/death, assessed up to 24 months
measure: Incidence of "per PDT" treatment-emergent Adverse Events
timeFrame: From the beginning of treatment with perPDT up to relapsing/death, assessed up to 24 months
measure: Quality of Life Questionnaire -C30 ( QLQ-C30)
timeFrame: Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months
measure: Quality of Life Questionnaire - Brain Cancer Module (QLQ-BN20)
timeFrame: Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months
Other outcomes:
measure: Analyze of Peripheral Blood Mononuclear Cells
timeFrame: Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHRU
Study officials:
affiliation: University Hospital, Lille
name: Nicolas Reyns, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vermandel M, Dupont C, Lecomte F, Leroy HA, Tuleasca C, Mordon S, Hadjipanayis CG, Reyns N. Standardized intraoperative 5-ALA photodynamic therapy for newly diagnosed glioblastoma patients: a preliminary analysis of the INDYGO clinical trial. J Neurooncol. 2021 May;152(3):501-514. doi: 10.1007/s11060-021-03718-6. Epub 2021 Mar 20.