INtraoperative photoDYnamic Therapy of GliOblastoma

Glioblastoma Clinical Trial

— INDYGO  

Official title:

A Pilot Study of the Feasibility of Intraoperative Photodynamic Therapy of Glioblastoma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03048240
• Other study ID #: 2016_06
• Secondary ID: 2016-002706-39
• Status: Completed
• Phase: N/A
• Start date: May 5, 2017
• Est. completion date: April 28, 2021

Study information

• Verified date: November 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 28, 2021
• Est. primary completion date: April 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHRU	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Analyze of Peripheral Blood Mononuclear Cells		Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months
Primary	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	Progression Free Survival (PFS)	Determined according to international RANO criteria	From the Date of diagnosis of glioblastoma until the date of Relapse defined, assessed up to 24 months
Secondary	Overall Survival (OS)	Determined according to international RANO criteria	From the date of Diagnosis of glioblastoma until the date of death, assessed up to 24 months
Secondary	Response to treatment	Evaluated by MRI every 3 months	From the date of perPDT until relapse/death, assessed up to 24 months
Secondary	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.	From the beginning of treatment with perPDT up to relapsing/death, assessed up to 24 months
Secondary	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.	Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months
Secondary	Quality of Life Questionnaire - Brain Cancer Module (QLQ-BN20)	Measuring the health-related quality of life in patients with brain cancer	Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months