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
- Jeffrey Raizer
- Status: Accepting New Patients
- 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
Find Related Clinical Trials
Browse by Disease Sites
Other Clinical Trials by Jeffrey Raizer
- A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein-Peptide Complex-96 (HSPPC-96)(NSC #725085, Alliance IND#15380) Vaccine Given with Bevacizumab Versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme (GBM)
- A Phase 2, Multicenter, Open-Label Study Of BGJ398 in Patients with Recurrent Resectable or Unresectable Glioblastoma
- Phase Ib/II multicenter study of buparlisib plus carboplatin or lomustine in patients with recurrent glioblastoma multiforme (GBM)
- An Open Label Phase 1b/2 Study of Orally Administered PLX3397 in Combination with Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma
- A Phase 1/2 Study of SL-701, a Subcutaneously Injected Multivalent Glioma-Associated Antigen Vaccine, in Adult Patients with Recurrent Glioblastoma Multiforme
- A Phase II Study of the Efficacy of Hypofractionated Radiation Therapy with Bevacizumab and Temozolomide Followed by Maintenance Temozolomide and Bevacizumab for Recurrent High-Grade Gliomas
- A Phase I-II trial Everolimus and Sorafenib in Patients with Recurrent High-Grade Gliomas BTTC09-01
- Phase I/II Adaptive Randomized Trial of Bevacizumab versus Bevacizumab plus Vorinostat in Adults with Recurrent Glioblastoma (BTTC11-02)
- A Phase II Trial of Oral Pazopanib plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A) without Prior Bevacizumab Exposure and (B) after Failing Prior Bevacizumab
- Natural History of Postoperative Cognitive Function, Quality Of Life, and Seizure Control in Patients with Supratentorial Low-Risk Grade II Glioma
- Phase II Randomized Study of Rituximab, Methotrexate, Procarbazine, Vincristine & Cytarabine with and without Low-Dose Whole-Brain Radiotherapy for Primary Central Nervous System Lymphoma
- Randomized Phase II of Concurrent Bevacizumab & Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma
last updated: 20-Sep-14 12:55 AM
Clinical trial availability changes frequently. Please check this site often for updates or call 312.695.1102 for personal assistance.