NCT00393783|Active Not RecruitingPhase 1
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Sponsor study identifier
interventional
13
1 country
1
Study Start
May 2006
Actual (reported)Primary Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2006
Actual (reported)October 26, 2006
Actual (reported)October 30, 2006
Actual (reported)May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The maximum tolerated dose over four dose levels
13 weeks
A secondary endpoint is to observe patients for any evidence of anti-tumor effect.
at week 19 or at the discretion of the physician
HER2 ECD DNA.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Mark Robson, MD
Memorial Sloan Kettering Cancer Center
13 participants (actual enrollment reported by the registry).
First Submitted
October 26, 2006
First Posted
October 30, 2006
Study Start
May 2006
Actual (reported)Primary Completion
Autologous Vaccination With Lethally Irradiated, Autologous Breast Cancer Cells Engineered to Secrete GM-CSF in Women With Operable Breast Cancer
Contact the study team to confirm eligibility.
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 8, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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