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

• Status: Terminated
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Brigham and Women's Hospital; Dana-Farber Cancer Institute; Harvard Medical School; Harvard Medical School (HMS and HSDM); National Cancer Institute (NCI); United States Department of Defense
• Treatments: Interleukin-12; Vaccines

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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