Phase 2
N=23
Neoadjuvant/Adjuvant Chemotherapy, Vaccine & Adjuvant Radiation Therapy in p53-Overexpressing Stage III Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00082641 ↗Enrolled (actual)
23
Serious AEs
26.1%
Results posted
Dec 2018
Primary outcome: Primary: Number of Participants Who Experienced Toxicity to the Vaccine — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- autologous dendritic cell-adenovirus p53 vaccine (Biological)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- Female
- Sponsor
- University of Nebraska
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Toxicity to the Vaccine |
0; 0 | — |
| PRIMARY Percent of Patients With an Immune Response to p53-infected Autologous Dendritic Cells |
100; 53 | — |
| PRIMARY Peak Immune Response as Measured by Number of Spots Per Cells |
8.54 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00082641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.