HER2/neu DNA Immunization for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Hormone therapy, Trastuzumab

Must not be taking: Corticosteroids

Disqualifiers: Pregnancy, Cardiac disease, Active cancers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

13 Participants Needed

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.

Research Team

Mark Robson, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of HER2/neu DNA to evaluate safety and immune response stimulation

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MAB HER 2 (HERCEPTIN)
• Xenogeneic HER2/Neu DNA Immunization

Trial Overview 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.

Participant Groups

Group I: 1 Experimental Treatment 1 Intervention

HER2 ECD DNA.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+