INtraoperative photoDYnamic Therapy of GliOblastoma (INDYGO)

• ClinicalTrials.gov Identifier: NCT03048240
• Recruitment Status: Completed
• First Posted: February 9, 2017
• Last Update Posted: June 6, 2022
• Sponsor: University Hospital, Lille
• Collaborator: Institut National de la Santé Et de la Recherche Médicale, France
• Information provided by (Responsible Party): University Hospital, Lille

Study Description

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

Condition or disease	Intervention/treatment	Phase
Glioblastoma	Device: "perPDT"; Drug: GLIOLAN	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of the Feasibility of Intraoperative Photodynamic Therapy of Glioblastoma.
• Actual Study Start Date: May 5, 2017
• Actual Primary Completion Date: April 28, 2021
• Actual Study Completion Date: April 28, 2021

Arms and Interventions

Arm

Intervention/treatment

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

Device: "perPDT"; 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).; Drug: GLIOLAN; patient will receive 5-ALA (5- alanine ,GLIOLAN drinkable) 4h before surgery

Outcome Measures

Primary Outcome Measures :

1. Number of Patients having the full "PerPDT" treatment with unacceptable and unexpected toxicities (grade ≥ 3) graded According to NCI CTC Version 4.0 [ Time Frame: From the intake of Gliolan (5-Ala) until 1 month post "perPDT" ]

   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

Secondary Outcome Measures :

1. Progression Free Survival (PFS) [ Time Frame: From the Date of diagnosis of glioblastoma until the date of Relapse defined, assessed up to 24 months ]
   Determined according to international RANO criteria
2. Overall Survival (OS) [ Time Frame: From the date of Diagnosis of glioblastoma until the date of death, assessed up to 24 months ]
   Determined according to international RANO criteria
3. Response to treatment [ Time Frame: From the date of perPDT until relapse/death, assessed up to 24 months ]
   Evaluated by MRI every 3 months
4. Incidence of "per PDT" treatment-emergent Adverse Events [ Time Frame: From the beginning of treatment with perPDT up to relapsing/death, assessed up to 24 months ]
   Collection of all Adverse events (AEs and SAEs) (according to NCI-CTC V4.0) and reviewing by an Independent Safety Monitoring Board.
5. Quality of Life Questionnaire -C30 ( QLQ-C30) [ Time Frame: Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months ]
   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.
6. Quality of Life Questionnaire - Brain Cancer Module (QLQ-BN20) [ Time Frame: Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months ]
   Measuring the health-related quality of life in patients with brain cancer

Other Outcome Measures:

1. Analyze of Peripheral Blood Mononuclear Cells [ Time Frame: Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

Hôpital Roger Salengro, CHRU

Lille, France

Sponsors and Collaborators

University Hospital, Lille

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

• Principal Investigator: Nicolas Reyns, MD, PhD; University Hospital, Lille

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University Hospital, Lille
• ClinicalTrials.gov Identifier: NCT03048240
• Other Study ID Numbers: 2016_06; 2016-002706-39 ( EudraCT Number )
• First Posted: February 9, 2017
• Last Update Posted: June 6, 2022
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:

Glioblastoma

Additional relevant MeSH terms:

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