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INtraoperative photoDYnamic Therapy of GliOblastoma (INDYGO)

Primary Purpose

Glioblastoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
"perPDT"
GLIOLAN
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Roger Salengro, CHRU

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

"perPDT"

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Progression Free Survival (PFS)
Determined according to international RANO criteria
Overall Survival (OS)
Determined according to international RANO criteria
Response to treatment
Evaluated by MRI every 3 months
Incidence of "per PDT" treatment-emergent Adverse Events
Collection of all Adverse events (AEs and SAEs) (according to NCI-CTC V4.0) and reviewing by an Independent Safety Monitoring Board.
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.
Quality of Life Questionnaire - Brain Cancer Module (QLQ-BN20)
Measuring the health-related quality of life in patients with brain cancer

Full Information

First Posted
January 24, 2017
Last Updated
June 3, 2022
Sponsor
University Hospital, Lille
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT03048240
Brief Title
INtraoperative photoDYnamic Therapy of GliOblastoma
Acronym
INDYGO
Official Title
A Pilot Study of the Feasibility of Intraoperative Photodynamic Therapy of Glioblastoma.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
April 28, 2021 (Actual)
Study Completion Date
April 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
Glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"perPDT"
Arm Type
Experimental
Arm Description
Single arm : per-operative PhotoDynamic Therapy (perPDT) during the surgery of Glioblastoma excision.
Intervention Type
Device
Intervention Name(s)
"perPDT"
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
GLIOLAN
Intervention Description
patient will receive 5-ALA (5- alanine ,GLIOLAN drinkable) 4h before surgery
Primary Outcome Measure Information:
Title
Number of Patients having the full "PerPDT" treatment with unacceptable and unexpected toxicities (grade ≥ 3) graded According to NCI CTC Version 4.0
Description
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
Time Frame
From the intake of Gliolan (5-Ala) until 1 month post "perPDT"
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
Determined according to international RANO criteria
Time Frame
From the Date of diagnosis of glioblastoma until the date of Relapse defined, assessed up to 24 months
Title
Overall Survival (OS)
Description
Determined according to international RANO criteria
Time Frame
From the date of Diagnosis of glioblastoma until the date of death, assessed up to 24 months
Title
Response to treatment
Description
Evaluated by MRI every 3 months
Time Frame
From the date of perPDT until relapse/death, assessed up to 24 months
Title
Incidence of "per PDT" treatment-emergent Adverse Events
Description
Collection of all Adverse events (AEs and SAEs) (according to NCI-CTC V4.0) and reviewing by an Independent Safety Monitoring Board.
Time Frame
From the beginning of treatment with perPDT up to relapsing/death, assessed up to 24 months
Title
Quality of Life Questionnaire -C30 ( QLQ-C30)
Description
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.
Time Frame
Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months
Title
Quality of Life Questionnaire - Brain Cancer Module (QLQ-BN20)
Description
Measuring the health-related quality of life in patients with brain cancer
Time Frame
Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months
Other Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Soy allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Reyns, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Roger Salengro, CHRU
City
Lille
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33743128
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.
Results Reference
derived

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INtraoperative photoDYnamic Therapy of GliOblastoma

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