drugset / Trial / NCT00082641

Neoadjuvant/Adjuvant Chemotherapy, Vaccine & Adjuvant Radiation Therapy in p53-Overexpressing Stage III Breast Cancer

NCT00082641 ↗

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

EvaluationDrugModalityDoseRoute
Subject autologous dendritic cell-adenovirus p53 vaccine Cell therapy — Subcutaneous