Immune-based therapies (vaccines) are a new focus of clinical investigation. These therapies
try to assist a patient's immune system (a system in our bodies that protects us against
infection) in killing tumors. One form of such therapy is the dendritic cell combined with
HER-2/neu (a type of protein over-expressed in some cancers) vaccine. Dendritic cells are
immune cells that can tell your immune system to fight infection. In laboratory testing,
these cells may also help the immune system attack tumors such as breast, kidney cancer or
skin cancer. The purpose of this research study is to determine if it is both possible and
safe to administer" this vaccine to patients with any HER2+ cancer.
We have demonstrated that administration of HER-2/neu pulsed DC1 in patients with DCIS
results in strong immunologic responses as well as clinical responses during a brief 4 or 6
week neoadjuvant vaccination. In subsets of patients with cancer HER-2 is over-expressed
including subsets of breast, gastric, pancreatic, brain, lung, and colon cancer. This trial
is designed for compassionate use of a HER-2/neu pulsed DC1 in patients with metastatic HER-2
positive cancer, who have no longer standard options to eliminate disease.
1. Age ≥ 18 years.
2. Subjects with active metastatic HER-2 positive cancer, at least 1+ by IHC, that have
already received standard therapy who have exhausted other treatment options.
3. Subjects with HER-2 1+ need to be HLA 2 or HLA A3 positive. There are no HLA
restrictions for HER-2 2+ or 3+.
4. Women of childbearing age with a negative pregnancy test documented prior to
5. Subjects with ECOG Performance Status Score of 0 or 1 (Appendix D).
6. Women of childbearing potential must agree to use a medically acceptable form of birth
control (medically accepted methods: birth control pills, condoms and spermicidal
lubricants, intrauterine device, and diaphragm) during their participation in the
7. Subjects who have voluntarily signed a written Informed Consent in accordance with
institutional policies after its contents have been fully explained to them.
1. Pregnant or lactating females.
2. Subjects with positive HIV or hepatitis C at baseline by self report.
3. Subjects with coagulopathies, including thrombocytopenia with platelet count <75,000,
INR > 1.5 and partial thromboplastin time > 50 sec
4. Subjects with major cardiac illness MUGA or ECHO < 50% EF.
5. Subjects with pre-existing medical illnesses or medications which might interfere with
the study as determined by PI.
6. Subjects receiving current therapy that may suppress immune system, such as steroids,
chemotherapy at the discretion of the PI.