1) Adenovirus p53 Infected DC Vaccine For Breast Cancer, 2) Translation of Biotechnology Into the Clinic

0371-02-FB

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.

2004-01-01

2009-05-01

2018-01-01

Completed

Early phase I

24

Inclusion Criteria: * Histologically confirmed invasive breast cancer meeting the following criteria: * Clinically locally advanced disease (stage III) with a primary tumor at least 4 cm by mammogram, ultrasound, or palpation AND/OR palpable axillary nodes larger than 1 cm * Planned neoadjuvant chemotherapy * p53-overexpressing tumor by immunohistochemistry * Delayed-type hypersensitivity to at least 1 of 3 standard antigens * Female * ECOG 0-1 * WBC \> 4,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Bilirubin \< 2 times upper limit of normal (ULN) * Hepatitis B surface antigen negative * Hepatitis C antibody negative * Creatinine \< 2 times ULNHIV negative * Fertile patients must use effective contraception during and for at least 6 months after study participation Exclusion Criteria: * No prior or concurrent autoimmune disorder * Not pregnant or nursing/negative pregnancy test * No other concurrent illness that would preclude study participation * No prior chemotherapy * No concurrent participation in another therapeutic clinical trial

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

2023-09-22