Super-selective Intra-arterial Cerebral Infusion of Trastuzumab for the Treatment of Cerebral Metastases of HER2/Neu Positive Breast Cancer
The purpose of this study is to evaluate the safety of administering a single dose of trastuzumab into the artery for the treatment of brain metastasis(es) from HER2/neu positive breast cancer.
This study will try to determine the best tolerated single dosage of trastuzumab administered into arteries by gradually increasing the dosage given to participants as the study progresses. Early participants will receive a dosage of 1 mg/kg. As more participants enroll into the study, this single dosage will be increased at designated levels up to 8 mg/kg, if it's determined to be safe to increase.
Trastuzumab is a type of antibody, which is a protein used by the body's immune system to fight against pathogens such as bacteria and viruses. This antibody binds to cell receptors known as the HER2/neu tyrosine kinase receptor. These receptors are expressed in certain cancer subtypes such as breast cancer. By blocking signaling through this HER2/neu receptor, trastuzumab can slow down or stop the over-expression of the HER2/neu protein. Over-expression of HER2/neu has been shown to play a role in the development and progression of certain types of breast cancer. Therefore, by slowing down or stopping the expression of HER2/neu, investigators hope to slow down or stop the growth of metastasis(es) and increase the responsiveness to therapy.
|Neoplasm Metastasis||Drug: Intra-arterial Cerebral Infusion of Trastuzumab||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1 Trial of Super-selective Intra-arterial Cerebral Infusion of Trastuzumab After Blood-Brain Barrier Disruption for the Treatment of Cerebral Metastases of HER2/Neu Positive Breast Cancer|
- Maximum tolerated dose (MTD) [ Time Frame: 30 days ]Maximum tolerated dose (MTD) the highest dose at which there are no dose limiting toxicities.
- Adverse events and dose-limiting toxicities [ Time Frame: 30 days ]A dose-limiting toxicity (DLT) will be defined as any grade 3 or 4 NCI Common Toxicity Criteria adverse event (CTCAE V4.0).
- Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 1 year ]RECIST Criteria
- Overall Survival (OS) [ Time Frame: 1 year ]
- Intracranial Time to Progression [ Time Frame: 1 year ]
|Study Start Date:||September 2015|
|Estimated Primary Completion Date:||September 2018 (Final data collection date for primary outcome measure)|
Experimental: Intra-arterial Cerebral Infusion of Trastuzumab
Super-selective Intra-arterial Cerebral Infusion of Trastuzumab After Blood-Brain Barrier Disruption
|Drug: Intra-arterial Cerebral Infusion of Trastuzumab|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02571530
|Contact: John Boockvar, MD||212-434-3900|
|Contact: Tamika Wong, MPHfirstname.lastname@example.org|
|United States, New York|
|Lenox Hill Brain Tumor Center||Recruiting|
|New York, New York, United States, 10075|
|Contact: John Boockvar, MD 212-434-3900|
|Contact: Tamika Wong, MPH 212-434-4836 email@example.com|
|Principal Investigator: John Boockvar, MD|
|Sub-Investigator: Jonathan Knisely, MD|
|Sub-Investigator: David Langer, MD|
|Sub-Investigator: Rafael Ortiz, MD|
|Sub-Investigator: Sherese Fralin, NP|
|Sub-Investigator: Ashley Ray, NP|
|Sub-Investigator: Karissa Tan, NP|
|Sub-Investigator: Tamika Wong, MPH|