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Intrathecal Trastuzumab for Leptomeningeal Metastases in HER2+ Breast Cancer

NCT01325207 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-09-26

Study results available
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Summary

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.

Conditions

Interventions

RADIATION

Trastuzumab

Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Raizer, MD · Northwestern University

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-01
Primary Completion
2016-06-20
Completion
2019-01-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01325207 on ClinicalTrials.gov