Pilot Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With HER-2 Positive Metastatic Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With HER-2 Positive

Conditions
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Metastatic Cancer

Intervention / Treatment
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* Biological: HER-2/neu Pulsed DC1 vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. 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. 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+. Women of childbearing age with a negative pregnancy test documented prior to enrollment. Subjects with ECOG Performance Status Score of 0 or 1 (Appendix D). 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 study. Subjects who have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them. - Exclusion Criteria: Pregnant or lactating females. Subjects with positive HIV or hepatitis C at baseline by self report. Subjects with coagulopathies, including thrombocytopenia with platelet count <75,000, INR > 1.5 and partial thromboplastin time > 50 sec Subjects with major cardiac illness MUGA or ECHO < 50% EF. Subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by PI. Subjects receiving current therapy that may suppress immune system, such as steroids, chemotherapy at the discretion of the PI.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: HER-2/neu Pulsed DC1 vaccine|There will be no exceptions to eligibility, contraindicated treatment/therapies/interventions or safety tests.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |