Clinical Trial NU 10C03
- Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer
- Principal Investigator
- Elena I. Pentsova
- Status: SUSPENDED
- Study Type: Therapeutic, Treatment
- Protocol No:.NU 10C03
- The purpose of this research study is to determine a safe dose of the drug Trastuzumab and then determine how effective this treatment is.
- 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.
Some of the eligibility criteria include:
- Participants must be at least 18 years of age.
- Participants must have breast cancer that’s spread to the layers of tissue that cover the brain and the spinal cord.
- Participants must have breast cancer that is HER2 positive.
- Description of Treatment
- Trastuzumab is an investigational drug which has not been approved by the Food and Drug Administration (FDA). Patients will be treated at one of 4 dose levels, but the dose given to each individual participant will remain the same throughout treatment. The study will begin by starting with a low dose that appears to be safe and increasing until the highest dose is met. If any one of the doses has too many side effects for participants, the rest of the participants will then be treated at the lower dose level. Prior to treatment, an Ommaya reservoir will be placed under the scalp. This device has a small catheter inserted into a fluid filled space and allows fluid to be removed and treatment to be instilled into it. Participants will remain on study as long as they are deriving benefit and are not having any bad side effects that are felt to be harmful.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 21-Aug-14 08:57 PM
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