HER2/neu DNA Immunization for Breast Cancer

Recruiting in Palo Alto (17 mi)

Mark E. Robson, MD - MSK Breast Medical ...

Overseen byCarlos Dos Anjos, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults over 18 with Stage III or metastatic breast cancer that has high levels of HER2. Participants must have finished previous treatments at least 4 weeks prior, can be on hormone therapy/trastuzumab, and should not have severe organ dysfunction or other active cancers. Pregnant women and those with certain heart conditions are excluded.

Inclusion Criteria

I am currently on hormonal therapy.

I am currently taking or have taken Herceptin for my cancer.

Pathology slides must be reviewed by the Department of Pathology at MSKCC

+8 more

Exclusion Criteria

It is expected that you may not live for more than 6 months.

I have a history of heart disease, including heart attack, heart failure, or other heart conditions.

You have a history of a weakened immune system or a condition where your immune system attacks your body.

+10 more

Participant Groups

The study tests the safety and immune response to an injected DNA vaccine containing a gene for rat HER2 protein. It aims to immunize patients against their own tumor cells by stimulating antibody and T-cell production in individuals with high HER2 expression tumors.

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment1 Intervention

HER2 ECD DNA.