INtraoperative photoDYnamic Therapy of GliOblastoma (INDYGO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03048240|
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : April 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Device: "perPDT" Drug: GLIOLAN||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of the Feasibility of Intraoperative Photodynamic Therapy of Glioblastoma.|
|Actual Study Start Date :||May 5, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Single arm : per-operative PhotoDynamic Therapy (perPDT) during the surgery of Glioblastoma excision.
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).
patient will receive 5-ALA (5- alanine ,GLIOLAN drinkable) 4h before surgery
- 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
- 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
- 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
- Response to treatment [ Time Frame: 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 [ 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.
- 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.
- 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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048240
|Contact: Nicolas Reyns, MD,PhDfirstname.lastname@example.org|
|Contact: Maximilien Vermandel, MDemail@example.com|
|Hôpital Roger Salengro, CHRU||Recruiting|
|Principal Investigator: Nicolas Reyns, MD,PhD|
|Principal Investigator:||Nicolas Reyns, MD, PhD||University Hospital, Lille|