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

NCT00082641 | Completed Phase 1 Results DMC

• 4 other identifiers: 0371-02-FBCDR0000354507NCI-2012-010193P30CA036727-20S1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Breast Cancer

Keywords

stage IIIA breast cancer; stage IIIB breast cancer

Outcome Measures

Primary Outcomes (3)

• Number of Participants Who Experienced Toxicity to the Vaccine

  This outcome measure looks at the safety of the vaccine by documenting the number of grade 2, 3, or toxicities experienced by participants related to the vaccine.

  1 week after each vaccine dose.

• Percent of Patients With an Immune Response to p53-infected Autologous Dendritic Cells

  Through study completion, an average of 18 months

• Peak Immune Response as Measured by Number of Spots Per Cells

  This outcome measure examined the importance of vaccine timing on antigen-specific relative to the primary cytotoxic therapy on the augmentation of antigen specific immune responses by measuring the duration of immune responses of participants

  6 months after last immunization

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive vaccination comprising p53-infected autologous dendritic cells subcutaneously (SC) 1 week after completion of doxorubicin and cyclophosphamide, 1 week after completion of paclitaxel (or after surgery for patients with stage III disease), and at 6 and 12 weeks after completion of radiotherapy (for a total of 4 vaccinations).

Biological: autologous dendritic cell-adenovirus p53 vaccine

Arm II

EXPERIMENTAL

Patients receive vaccination comprising p53-infected autologous dendritic cells SC at 6, 8, 10, and 12 weeks after completion of radiotherapy.

Biological: autologous dendritic cell-adenovirus p53 vaccine

Interventions

autologous dendritic cell-adenovirus p53 vaccine BIOLOGICAL

Given subcutaneously on one of two schedules

Arm I; Arm II

Eligibility Criteria

• Age: 19 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• National Cancer Institute (NCI): collaborator
• H. Lee Moffitt Cancer Center and Research Institute: collaborator

Study Sites (1)

Eppley Cancer Center, University of Nebraska Medical Center

Omaha, Nebraska, 68198-6805, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Elizabeth Reed
• Organization: University of Nebraska

ereed@unmc.edu

402-559-5166

Study Officials

• Elizabeth C Reed, MD

  University of Nebraska

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2004
• First Posted: May 19, 2004
• Study Start: January 1, 2004
• Primary Completion: May 1, 2009
• Study Completion: January 1, 2018
• Last Updated: September 22, 2023
• Results First Posted: December 12, 2018

Record last verified: 2023-09

Locations

US (1)