INtraoperative photoDYnamic Therapy of GliOblastoma

Not Applicable

Completed

• Conditions: Glioblastoma
• Interventions: Device: "perPDT"; Drug: GLIOLAN

• Registration Number: NCT03048240
• Lead Sponsor: University Hospital, Lille

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-24
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Study Start: 2017-05-05
• Status Verified: 2020-11
• Primary Completion: 2021-04-28
• Study Completion: 2021-04-28
• Last Update Submitted: 2022-06-03
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
"perPDT"	GLIOLAN	Single arm : per-operative PhotoDynamic Therapy (perPDT) during the surgery of Glioblastoma excision.
"perPDT"	"perPDT"	Single arm : per-operative PhotoDynamic Therapy (perPDT) during the surgery of Glioblastoma excision.

Primary Outcome Measures

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

Name	Time	Method
Progression Free Survival (PFS)	From the Date of diagnosis of glioblastoma until the date of Relapse defined, assessed up to 24 months	Determined according to international RANO criteria
Overall Survival (OS)	From the date of Diagnosis of glioblastoma until the date of death, assessed up to 24 months	Determined according to international RANO criteria
Quality of Life Questionnaire -C30 ( QLQ-C30)	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.
Response to treatment	From the date of perPDT until relapse/death, assessed up to 24 months	Evaluated by MRI every 3 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	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 - Brain Cancer Module (QLQ-BN20)	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

Trial Locations

Locations (1)

Hôpital Roger Salengro, CHRU; 🇫🇷 Lille, France