drugset / Trial / NCT01219907

Ex Vivo-Expanded HER2-Specific T Cells and Cyclophosphamide After Vaccine Therapy in Treating Patients With HER2-Positive Stage IV Breast Cancer

NCT01219907

Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE : Laboratory-treated T cells may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from HER2 peptides may help the body build an effective immune response to kill tumor cells that express HER2. Giving laboratory-treated T cells and cyclophosphamide after vaccine therapy may be an effective treatment for breast cancer. PURPOSE: This phase I trial is studying the side effects and best dose of ex vivo-expanded HER2-specific T cells when given together with cyclophosphamide after vaccine therapy in treating patients with HER2-positive stage IV breast cancer.

Timeline

Start
2012-06
Primary completion
2014-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject HER-2/neu peptide vaccine Vaccine Other
Subject ex vivo-expanded HER2-specific T cells Cell therapy Intravenous
Background Cyclophosphamide Other / unclassified Intravenous