Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

patient will receive 5-ALA 4 to 6 hours before surgery

Gliolan

The protocol requires the realization of specific procedures in addition to the usual care.

The intra-operative photodynamic therapy ("intraoperative PDT") added to surgery for glioblastoma excision. The patient will receive 5-ALA ( 5-aminolevulinic acid hydrochloride),GLIOLAN drinkable 6h before surgery + lighting of the tumor bed by a red light source (laser with different J/cm²) at the end of resection (Prolonged surgery of 45 minutes).

Intraoperative PDT

Nicolas Reyns, MD,PhD

Maximilien Vermandel, MD

Florence Lefranc, MD

The phase II study evaluate a light dose escalation in a classical intraoperative PDT regimen mediated by 5-ALA-PpIX, in glioblastoma patients with access to full surgical removal of the contrast enhancement. This treatment will be performed in addition to the current reference treatment of glioblastoma: maximum removal surgery followed by radiochemotherapy according to the Stupp protocol.

Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma

A Multi-center Phase II Study With Light Dose Escalation During Intraoperative Photodynamic Therapy of Glioblastoma

Dose level above which TDL is observed in more than 33% (i.e., d̀-\> 2 of 6) of subjects in an arm

Number of patients without relapse within 25 mm of surgical site defined according to International RANO criteria

Median of progression-free survival time determined according to international RANO criteria

Median of OS determined according to international RANO criteria

Evaluated by MRI/ TEP 11C-MET every 3 months

Collection of all Adverse events (AEs and SAEs) (according to NCI-CTCE V5.0) and reviewing by an Independent Safety Monitoring Board

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

Measuring the health-related quality of life in patients with brain cancer

Institut National de la Santé Et de la Recherche Médicale, France

Hemerion Therapeutics

University Hospital, Lille

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Pleural Diseases

Mesothelioma

Mesothelioma, Malignant

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Malignant Mesothelioma

Antineoplastic Agents

Central Nervous System Depressants

Immunomodulating Agents

Dihematoporphyrin Ether

Trioxsalen

Hematoporphyrin Derivative

Ether

Photosensitizing Agents

Patients receive porfimer sodium IV over 3-5 minutes 24-48 hours prior to standard of care VATS, followed by photodynamic therapy

Porfimer Sodium

Video-Assisted Thoracic Surgery

Photodynamic Therapy

Subjects will receive one course of light therapy at the time of surgery

ASK Roswell

Saikrishna S. Yendamuri

• Saikrishna Yendamuri, MD

This phase I trial evaluates the side effects of intraoperative photodynamic therapy with porfimer sodium in enhancing the response to immunotherapy with an immune checkpoint inhibitor drug in patients with non-small cell lung cancer with pleural disease. Photodynamic therapy is a technique that that works by combining a photosensitizing agent (porfimer sodium in this trial) and an intense light source to kill tumor cells. Photodynamic therapy may decrease the patients' symptoms and improve their quality of life.

Photodynamic Therapy to Amplify the Response to Immunotherapy in Patients With Non-small Cell Lung Cancer With Pleural Disease

Utilizing Photodynamic Therapy to Amplify the Response to Immunotherapy in Patients With Non-Small Cell Lung Cancer (NSCLC) With Pleural Disease or Malignant Pleural Mesothelioma (MPM) - Phase I Study

Will be determined by recording the occurrence of SAE during the first 28 days post study-related immunotherapy. The SAE will be evaluated using the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Will utilize Kaplan-Meier curves to descriptively examine dose level differences and generate summary statistics.

Will be analyzed using a repeated measures analysis-of-variance (ANOVA) model with a factor for dose level time and a dose level by time interaction.

Will be analyzed using a repeated measures ANOVA model with a factor for dose level, time and a dose level by time interaction.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma	NCT04391062	Glioblastoma	Gliolan Intraoperative ...	18 Years -	University Hospital, Lille
Photodynamic Therapy to Amplify the Response to Immunotherapy in Patients With Non-small Cell Lung Cancer With Pleural Disease	NCT04836429	Lung Non-Small ... Pleural Disorde...	Porfimer Sodium Video-Assisted ... Photodynamic Th... Intraoperative ...	18 Years -	Roswell Park Cancer Institute
Photodynamic Therapy to Amplify the Response to Immunotherapy in Patients With Non-small Cell Lung Cancer With Pleural Disease	NCT04836429	Lung Non-Small ... Pleural Disorde...	Porfimer Sodium Video-Assisted ... Photodynamic Th... Intraoperative ...	18 Years -	Roswell Park Cancer Institute

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