MDA2014-04-02 VADIS: Phase II trial of Nelipepimut-S Peptide Vaccine in Women with DCIS of the Breast

Protocol: 
AAAQ8038
Phase: 
II

MDA2014-04-02 VADIS: Phase II trial of Nelipepimut-S Peptide Vaccine in Women with DCIS of the Breast

The goal of this clinical research is to learn if NeuVax can help stimulate the immune system to recognize and kill abnormal cells present in DCIS and to study the safety of this vaccine. The immune system can defend the body against cancer. The vaccine is intended to strengthen this defense. NeuVax is a vaccine designed to help the immune system recognize tumor cells that express the HER2 protein. NeuVax is made up of 2 parts: nelipepimut-S and GM-CSF. GM-CSF is short for recombinant human granulocyte-macrophage colony stimulating factor. GM-CSF is a growth factor drug commonly used to increase the number of white blood cells in patients having cancer treatment. Nelipepimut-S peptide is a piece of the HER2 protein. By injecting these 2 substances into the skin, the immune system may be able to target cancer cells that express the HER2 protein and attack them with the white blood cells. This may cause the cancer cells to die and may help prevent the cancer from coming back. As part of this study, participants will receive either six vaccinations of NeuVax or six vaccinations of GM-CSF alone. GM-CSF alone has no vaccine qualities and will provide a comparison group for NeuVax.

Are you Eligible? (Inclusion Criteria)

1) Participants must have a diagnosis of DCIS made by core needle biopsy.
2) Participants must have an area of radiographic abnormality measuring at least 1 cm.
3) Participants must be HLA-A2 positive
4) Participant oes not have invasive breast cancer

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States