drugset / Trial / NCT00082641
Neoadjuvant/Adjuvant Chemotherapy, Vaccine & Adjuvant Radiation Therapy in p53-Overexpressing Stage III Breast Cancer
Phase 1/2
Completed
24 enrolled
University of Nebraska
H. Lee Moffitt Cancer Center and Research Institute · collabNational Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving vaccine therapy before and/or after chemotherapy and radiation therapy may cause a stronger immune response. PURPOSE: This randomized phase I/II trial is studying the side effects of two regimens of vaccine therapy and to see how well they work in treating women who are receiving neoadjuvant or adjuvant chemotherapy and adjuvant radiation therapy for stage III breast cancer that overexpresses p53.
Timeline
- Start
- 2004-01-01
- Primary completion
- 2009-05-01
- Completion
- 2018-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | autologous dendritic cell-adenovirus p53 vaccine | Cell therapy | — | Subcutaneous |