Status:
COMPLETED
Neoadjuvant/Adjuvant Chemotherapy, Vaccine & Adjuvant Radiation Therapy in p53-Overexpressing Stage III Breast Cancer
Lead Sponsor:
University of Nebraska
Collaborating Sponsors:
National Cancer Institute (NCI)
H. Lee Moffitt Cancer Center and Research Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
19-120 years
Phase:
PHASE1
PHASE2
Brief 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 tu...
Detailed Description
OBJECTIVES: * Determine the safety and toxicity of two different schedules of vaccination comprising p53-infected autologous dendritic cells in women with p53-overexpressing stage III breast cancer u...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00082641
Start Date
January 1 2004
End Date
January 1 2018
Last Update
September 22 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Eppley Cancer Center, University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805