Intrathecal Trastuzumab Administration in Metastatic Breast Cancer Patients Developing Carcinomat… (NCT01373710) | Clinical Trial Compass
CompletedPhase 1/2
Intrathecal Trastuzumab Administration in Metastatic Breast Cancer Patients Developing Carcinomatous Meningitis
France34 participantsStarted 2011-05-19
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Metaplastic Infiltrating adenocarcinoma of the breast
* HER2 Overexpression by IHC and / or amplification (FISH and or ICHS)
* Positive diagnosis of neoplastic meningitis: positive CSF cytology (obtained within 28 days before inclusion) AND / OR clinical symptoms of neoplastic meningitis and aspect of tumoral meningitis on MRI
* Brain metastases are allowed without prior treatment, if they are asymptomatics and without engagement. In cases of symptomatic brain metastases, subjects could be included only if surgery and / or radiotherapy (stereotactic or in toto) were performed and if the cerebral metastatic localization allow IT or intra-ventricular treatment. The last radiotherapy session or the surgery must have been done 3 weeks before.
* Aged 18 years old or more
* Male and female
* Life expectancy more than 2 months
* Satisfactory Cardiac function: left ventricular ejection fraction (LVEF) determined by ultrasound scan or myocardial scintigraphy
* Adequate Biological functions 14 days before inclusion, according to the criteria below: Neutrophils \> 1.0 x 109/L, Hemoglobin \> 9.0 g/dL (+ transfusion if needed,Platelets \> 50 x 109/L,Bilirubin \< 3 x N, ALT \& AST \< 10 x N, Creatinine \< 2.0 mg/dL, Clearance \> 25 mL/min (Cockcroft and Gault formula), Prothrombin time \> 70 %, Kaolin cephalin coagulation time \< 1.5 x N.
* Women of childbearing potential, must take adequate birth control measure during the study period and must have a negative pregn…
What they're measuring
1
Phase I : To determine the Trastuzumab maximum tolerated dose (MTD) when weekly administrated by intrathecal or intraventricular route.