INtraoperative photoDYnamic Therapy of GliOblastoma

NCT03048240 | Completed DMC

• 2 other identifiers: 2016_062016-002706-39
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Glioblastoma

Keywords

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Number of Patients having the full "PerPDT" treatment with unacceptable and unexpected toxicities (grade ≥ 3) graded According to NCI CTC Version 4.0

  In particular, the following complications will be investigated: severe infection, new neurological deficit responsible for severe disability, status epilepticus, deaths during the postoperative period. Target: At least 6/10 patients who benefited of complete "PerPDT" and without unacceptable and unexpected toxicities

  From the intake of Gliolan (5-Ala) until 1 month post "perPDT"

Secondary Outcomes (6)

• Progression Free Survival (PFS)

  From the Date of diagnosis of glioblastoma until the date of Relapse defined, assessed up to 24 months

• Overall Survival (OS)

  From the date of Diagnosis of glioblastoma until the date of death, assessed up to 24 months

• Response to treatment

  From the date of perPDT until relapse/death, assessed up to 24 months

• Incidence of "per PDT" treatment-emergent Adverse Events

  From the beginning of treatment with perPDT up to relapsing/death, assessed up to 24 months

• Quality of Life Questionnaire -C30 ( QLQ-C30)

  Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months

Other Outcomes (1)

• Analyze of Peripheral Blood Mononuclear Cells

  Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months

Study Arms (1)

"perPDT"

EXPERIMENTAL

Single arm : per-operative PhotoDynamic Therapy (perPDT) during the surgery of Glioblastoma excision.

Device: "perPDT"; Drug: GLIOLAN

Interventions

"perPDT" DEVICE

The protocol requires the realization of specific procedures in addition to the usual care. The per-operative photodynamic therapy ("perPDT") added to surgery for glioblastoma excision. The patient will receive 5-ALA (5- alanine ,GLIOLAN drinkable) 4h before surgery + lighting of the tumor bed by a light source (laser) at the end of resection (Prolonged surgery of 45 minutes).

"perPDT"

GLIOLAN DRUG

patient will receive 5-ALA (5- alanine ,GLIOLAN drinkable) 4h before surgery

"perPDT"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient male or female ≥18 years
• General status (WHO) of Performance status 0, 1 or 2
• Probable glioblastoma according to clinical and radiological criteria,
• whose surgical indication was given in Multidisciplinary consultation meeting (RCP) of neurooncology,
• Decision to treat the patient as part of the Clinical trial also taken 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 scheduled at the hospital CHRU of Lille, center of reference of the region
• 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
• Patient assigned to an heath insurance

You may not qualify if:

• Contraindications to 5-ALA (Gliolan®) and to per-operative PhotoDynamic Therapy "perPDT":
• 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)
• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Hôpital Roger Salengro, CHRU

Lille, France

Location

Related Publications (2)

• 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.

  PMID: 33743128 RESULT

• Peciu-Florianu I, Vannod-Michel Q, Vauleon E, Bonneterre ME, Reyns N. Long term follow-up of patients with newly diagnosed glioblastoma treated by intraoperative photodynamic therapy: an update from the INDYGO trial (NCT03048240). J Neurooncol. 2024 Jul;168(3):495-505. doi: 10.1007/s11060-024-04693-4. Epub 2024 May 16.

  PMID: 38753093 DERIVED

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Nicolas Reyns, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: February 9, 2017
• Study Start: May 5, 2017
• Primary Completion: April 28, 2021
• Study Completion: April 28, 2021
• Last Updated: February 5, 2026

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)