Xenogeneic HER2/Neu DNA Immunization for Patients With Metastatic and High Risk Breast Cancer: A Phase I Study to Assess Safety and Immunogenicity
The purpose of this study is to evaluate whether the injection of HER2/neu DNA is safe and stimulates an immune response.
The immune system consists of different kinds of cells and substances which help fight against infections and inflammation in the body. These antibodies and T-cells are part of the immune system that may also help to fight against tumor cells. One way to make antibodies and stimulate T-cells is to inject the patient with a preparation which contains material that may stimulate the immune system. This process is called an immunization. We are trying to immunize the patient against HER2/neu. In order to participate in this trial, the tumor must have a large amount of HER2/neu on its surface. The injection that the patient will receive in this trial is a piece of DNA made in bacteria which contains the gene for rat HER2. DNA is material which contains the information needed to produce many substances in the body. The HER2 gene encodes for a protein known as HER2.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Xenogeneic HER2/Neu DNA Immunization for Patients With Metastatic and High Risk Breast Cancer: A Phase I Study to Assess Safety and Immunogenicity|
- The maximum tolerated dose over four dose levels [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
- A secondary endpoint is to observe patients for any evidence of anti-tumor effect. [ Time Frame: at week 19 or at the discretion of the physician ] [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
HER2 ECD DNA.
Biological: MAB HER 2 (HERCEPTIN)
Rat HER2 DNA will be delivered intramuscularly at four different dose levels (0.5mg, 1mg, 3mg, or 6mg) during weeks 1, 4, 7, 10 and 13 for five injections.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393783
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Teresa Gilewski, MD||Memorial Sloan Kettering Cancer Center.|