Intrapleural Photodynamic Therapy in a Multimodal Treatment for Patients With Malignant Pleural Mesothelioma

PHASE2CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

January 16, 2016

Primary Completion Date

March 12, 2018

Study Completion Date

March 13, 2018

Conditions
Malignant Pleural Mesothelioma
Interventions
DEVICE

photodynamic therapy (PDT)

"Intra-operative (intrapleural) photodynamic therapy (PDT): briefly, each patient will receive porfimer sodium (PHOTOFRIN®) (2 mg/kg) 24 hours before eP/D (IV injection on 3-5 minutes). Cutaneous light precautions will be instituted immediately and for the next 4 weeks.~After complete macroscopic resection of the tumour, the thoracic surgeon and his team will set isoprobes (7 at least) in the pleural cavity to monitor by a dosimetry device the correct illumination of the cavity with a visible red light (wavelength of 630 nm; laser source). PDT-related postoperative considerations include light precautions, intensive focus on perioperative nutrition, and a greater than normal fluid requirement in the immediate postoperative period."

PROCEDURE

thoracic surgery Pleurectomy / extended Decortication

extended P/D is intended to remove any macroscopic tumor including the parietal and visceral pleura when the diaphragm and / or the pericardium was resected

DRUG

Adjuvant chemotherapy

Chemotherapy should begin up to three months after surgery. It consists of pemetrexed 500 mg / m2 followed 30 minutes later by cisplatin 75 mg / m2 (in the usual manner from the center to the chemotherapy) on day 1 (J1) of each cycle every 3 weeks, for up to 6 cycles.

Trial Locations (1)

Unknown

CHRU de Lille Hôpital Calmette, Lille

All Listed Sponsors
collaborator

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

OTHER_GOV

collaborator

University of Pennsylvania

OTHER

collaborator

Région Nord-Pas de Calais, France

OTHER

lead

University Hospital, Lille

OTHER

NCT02662504 - Intrapleural Photodynamic Therapy in a Multimodal Treatment for Patients With Malignant Pleural Mesothelioma | Biotech Hunter | Biotech Hunter