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Intrathecal Trastuzumab for Leptomeningeal Metastases in HER2+ Breast Cancer


Title Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Cancer
Therapeutic Area Brain Tumors
Principal Investigator Suriya Jeyapalan, MD
Min Age 18 Years
Gender Both
Contact Amy Quinkert
617-636-8589
More Information https://clinicaltrials.gov/ct2/show/NCT01325207

Overview

The purpose of this the study that you are now being asked to participate in is to determine how safe and effective the study drug, trastuzumab, is in patients with HER-2 positive cancer that has spread to the fluid around the brain and spinal cord.

Study Details

Inclusion Criteria

  • HER2+ cancer with leptomeningeal metastasis.
  • Eligible to have an Ommaya reservoir placed.
  • Otherwise normal organ function.

Exclusion Criteria

  • No pregnant or nursing women.
  • No known allergy to trastuzumab.
  • Cannot be currently receiving radiation therapy to the brain or chemotherapy that has CNS penetration (e.g. temozolomide, BCNU, CCNU, etoposide, xeloda, carboplatin, navelbine, bevacizumab, CPT-11, and topotecan).

Study Requirements

After placement of the Ommaya reservoir, subjects will come to the hospital to receive intrathecal (into the fluid space of the brain) trastuzumab twice a week for 4 weeks, once a week for 4 weeks, and every other week thereafter. Subjects will stop receiving trastuzumab if their disease progresses or if they have bad side effects while on trastuzumab. After stopping trastuzumab, research staff will contact subjects every 2-3 months to see how they are doing.