Phase 1-2 Study of Safety and Efficacy of Intrathecal Trastuzumab Administration in Metastatic HER2 Positive Breast Cancer Patients Developing Carcinomatous Meningitis
Phase I: Secondary Outcome Measures:
Recommended dose (RD will be used in Phase II) Toxicity during treatment Clinical response
to specific neurologic symptoms Time to neurologic progression Biological response: CSF
cellularity and protein concentration Radiological response: cerebrospinal meningitis and
neuraxis RMI Impact on quality of life Impact on survival (overall survival, survival
without neurological progression, progression-free survival) Pharmacokinetics: dose of
trastuzumab in CSF and plasma FCGR3A Genetic status influence on efficacy trastuzumab in
metastatic breast cancer
Phase II: Secondary Outcome Measures :
Toxicity during treatment Clinical response to specific neurologic symptoms Time to
neurologic progression Biological response: CSF cellularity and protein concentration
Radiological response: cerebrospinal meningitis and neuraxis MRI Impact on quality of life
Impact on survival (overall survival, survival without neurological progression,
progression-free survival) Pharmacokinetics: dose of trastuzumab in CSF and plasma
(confirmation of phase I data with 5 patients) FCGR3A Genetic status influence on efficacy
trastuzumab in metastatic breast cancer
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I : To determine the Trastuzumab maximum tolerated dose (MTD) when weekly administrated by intrathecal or intraventricular route.
Phase I : To determine the Trastuzumab maximimum 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).
2 months
Yes
Maya Gutierrez, MD
Study Director
Institut Curie - Hopital Rene Huguenin - Saint-Cloud - France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
09/501/M
NCT01373710
May 2011
May 2015
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