Intrathecal Trastuzumab Administration in Metastatic Breast Cancer Patients Developing Carcinomatous Meningitis
Status:
Completed
Trial end date:
2018-04-09
Target enrollment:
Participant gender:
Summary
The purpose of this study is:
Phase I: To determine the Trastuzumab maximum tolerated dose (MTD) when weekly administrated
by intrathecal or intraventricular route to reach a intra CSF target concentration (30 µg/mL)
near the conventional therapeutic concentration and depending on the dose-limiting toxicity
(DLT)
Phase II: Determination of antitumor activity trastuzumab when administrated by IT or
intra-ventricular in terms of neurological progression-free survival at 2 months
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Institut Curie
Collaborators:
Centre Francois Baclesse Centre Leon Berard Centre Oscar Lambret Groupe Hospitalier Pitie-Salpetriere Hoffmann-La Roche Institut Bergonié Institut du Cancer de Montpellier - Val d'Aurelle University Hospital, Grenoble University Hospital, Toulouse