Vaccination of Patients With Breast Cancer With Dendritic Cell/Tumor Fusions and IL-12

Stopped early · Phase 1/Phase 2

Conditions studied: Breast Cancer

In brief

The purpose of this study is to test the safety of an investigational Dendritic Cell/Tumor Fusion vaccine given with IL-12 for patients with breast cancer. RATIONALE: Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Interleukin-12 may stimulate the white blood cells to kill tumor cells. Giving vaccine therapy together with interleukin-12 may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of interleukin-12 when given together with vaccine therapy and to see how well they work in treating women with stage IV breast cancer.

Key facts

Study ID

NCT00622401

Run by

Beth Israel Deaconess Medical Center

People needed

8

Starts

2009-12-01

Expected to finish

2014-10-01

Last updated by the study team

2017-11-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Stage IV breast cancer with measurable disease and accessible tumor
• ECOG Performance Status 0-2 with greater than six week life expectancy
• 18 years of age or older
• Laboratory values as outlined in the protocol

You may not qualify if…

• Patients must not have received other immunotherapy treatment in the three months prior to the initial vaccination
• Patients may not be on herceptin therapy during this protocol and may not have received it for four weeks prior to initial vaccination
• Patients must not have received weekly chemotherapy or hormonal treatment for two weeks prior to the initial vaccination and must not have received monthly chemotherapy for four weeks prior to the initial vaccination
• Clinical evidence of CNS disease
• Clinically significant autoimmune disease
• Patients who are HIV+
• Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
• Pregnant of lactating women will be excluded, all premenopausal women must undergo pregnancy testing

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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