Intrathecal Trastuzumab for Leptomeningeal Metastases in HER2+ Breast Cancer

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Intrathecal Trastuzumab for Leptomeningeal Metastases in HER2+ Breast Cancer

This study is currently recruiting participants.
Verified January 2014 by Northwestern University
Sponsor:
Northwestern University
Information provided by (Responsible Party):
Northwestern University

ClinicalTrials.gov Identifier:
NCT01325207
First received: March 7, 2011
Last updated: January 13, 2014
Last verified: January 2014
History of Changes

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Purpose The drug being studied is Trastuzumab, a medicine that is used to slow or stop the growth of cancerous tumors that are HER-2 positive. Patients are being asked to participate in this study because they have been diagnosed with having tumor cells in their spinal fluid. This study will investigate the safety and effects of this drug when given directly into the spinal fluid.
Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer The purpose of this research study is to determine a safe dose of the drug Trastuzumab and then determine how effective this treatment is.

Condition Intervention Phase Breast Cancer
Radiation: Trastuzumab
Phase 1
Phase 2

Study Type: Interventional Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment Official Title: Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer


http://clinicaltrials.gov/show/NCT01325207