Protocol
04-101
Full Title
Xenogeneic HER2/NEU DNA Immunization for Patients with Metastatic or High Risk Breast Cancer: a Phase I Study to Assess Safety and Immunogenicity
Purpose
Scientists are developing immunological therapies that trigger a response by a patient’s immune system against the cancer. The purpose of this study is to determine the highest dose of an immunotherapy called HER2/neu immunization that can be given safely, and to see if this preparation can stimulate an immune response in women with breast cancer that has metastasized (spread) or has a high risk of metastasizing.
Antigens are targets for immune cells. If an immune cell recognizes an antigen on a tumor cell, it may help to trigger a reaction against the tumor. The immunization prepared for this clinical trial targets an antigen called the HER2 protein, which is over-produced by some breast cancer cells.
The injection used in this study is a piece of DNA (genetic material) made in bacteria which contain the gene for rat HER2.
Investigator
Co-Investigators
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must be women with metastatic breast cancer or stage III breast cancer that has a high risk of metastasizing. Patients’ breast tumors must overexpress the HER2/neu protein.
- At least 4 weeks must have passed since completion of prior surgery, chemotherapy, radiation therapy, or antibody therapy (such as trastuzumab), and patients must have recovered from any side effects.
- Patients must be age 18 or older.
For more information and to see if you are eligible for this study, please contact Dr. Teresa Gilewski at 646-888-5451.
Disease(s)
Breast Cancer
Locations
ClinicalTrials.gov
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