NCT03048240CompletedNot Applicable
A Pilot Study of the Feasibility of Intraoperative Photodynamic Therapy of Glioblastoma.
University Hospital, Lille1 site in 1 country10 target enrollmentStarted: May 5, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Number of Patients having the full "PerPDT" treatment with unacceptable and unexpected toxicities (grade ≥ 3) graded According to NCI CTC Version 4.0
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
"perPDT"
Experimental
Single arm : per-operative PhotoDynamic Therapy (perPDT) during the surgery of Glioblastoma excision.
Intervention: "perPDT" (Device)
"perPDT"
Experimental
Single arm : per-operative PhotoDynamic Therapy (perPDT) during the surgery of Glioblastoma excision.
Intervention: GLIOLAN (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- 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)
- Quality of Life Questionnaire -C30 ( QLQ-C30)(Every 3 months from the signature of Consent form until relapse/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 - Brain Cancer Module (QLQ-BN20)(Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months)
Investigators
Study Sites (1)
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