Intrapleural Photodynamic Therapy in a Multimodal Treatment for Patients With Malignant Pleural Mesothelioma
Status:
Completed
Trial end date:
2018-03-13
Target enrollment:
Participant gender:
Summary
Malignant pleural mesothelioma (MPM) is an aggressive tumour with poor prognosis (median
survival <13 months), and high resistance to chemotherapy. Extended pleurectomy/decortication
(eP/D) is a debulking surgery of MPM but cannot be considered as a curative treatment.
Therefore it has been suggested that eP/D may be of interest if combined with intra-operative
treatment and adjuvant therapies.
Photodynamic Therapy (PDT) is an innovative treatment based on the rationale that tumour
cells, if previously treated with photosensitizing drugs (Photofrin), will die when exposed
to light at a particular wavelength. Interestingly PDT might also stimulate anti-tumour
immune response through the release of tumour antigens and induced inflammation.
PDT was tested in phase I-II trials for MPM in combination with EPP or eP/D, and
chemotherapy. US studies from J Friedberg et al found very promising survival results in MPM
when combining eP/D, but not EPP, intra-operative PDT and chemotherapy
(cisplatin-pemetrexed), with a median overall survival of 31.7 months.
However, the definitive value of intra-pleural PDT combined to eP/D in the treatment of MPM
still need to be validated. The same multimodal treatment has been established in Lille, the
French national expert centre for MPM, with the help of our american colleagues. Therefore,
this phase II trial proposes to patients to benefit from the combination of eP/D,
intra-operative PDT then chemotherapy by cisplatin-pemetrexed and prophylactic radiotherapy.
Primary endpoint is the feasibility for the patients to have the full multimodal treatment of
MPM including intrapleural PDT without unacceptable or unexpected grade III-IV toxicities.
Secondary endpoints are PFS, OS, ORR, and quality of life. If the feasibility of such
treatment would be confirmed in France, a multicentric, randomized trial comparing this
experimental treatment vs control arm (same multimodal treatment without PDT) is planned.
Phase:
Phase 2
Details
Lead Sponsor:
University Hospital, Lille
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France Région Nord-Pas de Calais, France University of Pennsylvania