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Intrathecal Trastuzumab Administration in Metastatic Breast Cancer Patients Developing Carcinomatous Meningitis

NCT01373710 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-11-24

No results posted yet for this study

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

Conditions

Interventions

DRUG

Trastuzumab

One injection per week during 8 weeks by lumbar puncture or Ommaya Reservoir. 4 levels of doses are expected from 30 mg to 150 mg

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Centre Leon Berard

    collaborator OTHER

  • Groupe Hospitalier Pitie-Salpetriere

    collaborator OTHER

  • Centre Oscar Lambret

    collaborator OTHER

  • Centre Francois Baclesse

    collaborator OTHER

  • Institut Bergonié

    collaborator OTHER

  • University Hospital, Toulouse

    collaborator OTHER

  • Institut du Cancer de Montpellier - Val d'Aurelle

    collaborator OTHER

  • University Hospital, Grenoble

    collaborator OTHER

  • Institut Curie

    lead OTHER

Principal Investigators

  • Maya Gutierrez, MD · Institut Curie - Hopital Rene Huguenin - Saint-Cloud - France

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-19
Primary Completion
2018-04-30
Completion
2018-04-09

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
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 NCT01373710 on ClinicalTrials.gov