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Vaccine Therapy With Either Neoadjuvant or Adjuvant Chemotherapy and Adjuvant Radiation Therapy in Treating Women With p53-Overexpressing Stage III Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00082641
Recruitment Status : Completed
First Posted : May 19, 2004
Results First Posted : December 12, 2018
Last Update Posted : February 5, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
H. Lee Moffitt Cancer Center and Research Institute
Information provided by (Responsible Party):
Elizabeth Reed, MD, University of Nebraska

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Cancer Biological: autologous dendritic cell-adenovirus p53 vaccine Phase 1 Phase 2

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 undergoing neoadjuvant or adjuvant chemotherapy and adjuvant radiotherapy.
  • Determine the immune response, in terms of humoral and cellular response, in patients treated with these regimens.
  • Determine antigen-specific immune responses in patients treated with these regimens.

OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.

All patients undergo apheresis for the collection of peripheral blood monocytes that are cultured with interleukin-4 and sargramostim (GM-CSF) to produce dendritic cells. The dendritic cells are infected with a recombinant adenoviral vector containing the wild-type p53 gene.

Patients receive doxorubicin IV and cyclophosphamide IV every 2 weeks for 8 weeks (4 courses) followed 2 weeks later by paclitaxel IV every 2 weeks for 8 weeks (4 courses). Patients with stage III disease then undergo surgery. Three weeks after completion of paclitaxel (or after surgery for patients with stage III disease), patients undergo radiotherapy once daily for 6.5 weeks. Patients are then receive vaccine therapy as per the arm to which they were randomized.

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

Treatment in both arms continues in the absence of unacceptable toxicity.

Patients are followed at 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-50 patients (10-25 per treatment arm) will be accrued for this study within 2 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 1) Adenovirus p53 Infected DC Vaccine For Breast Cancer, 2) Translation of Biotechnology Into the Clinic
Study Start Date : January 2004
Actual Primary Completion Date : May 2009
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I
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
Given subcutaneously on one of two schedules
Experimental: Arm II
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
Given subcutaneously on one of two schedules


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Who Experienced Toxicity to the Vaccine [ Time Frame: 1 week after each vaccine dose. ]
    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.

  2. Percent of Patients With an Immune Response to p53-infected Autologous Dendritic Cells [ Time Frame: Through study completion, an average of 18 months ]
  3. Peak Immune Response as Measured by Number of Spots Per Cells [ Time Frame: 6 months after last immunization ]
    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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 19 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC > 4,000/mm^3
  • Platelet count > 100,000/mm^3

Hepatic

  • Bilirubin < 2 times upper limit of normal (ULN)
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative

Renal

  • Creatinine < 2 times ULN

Immunologic

  • HIV negative
  • No prior or concurrent autoimmune disorder

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 6 months after study participation
  • No other concurrent illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics

Other

  • No concurrent participation in another therapeutic clinical trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082641


Locations
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United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805
Sponsors and Collaborators
University of Nebraska
National Cancer Institute (NCI)
H. Lee Moffitt Cancer Center and Research Institute
Investigators
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Study Chair: Elizabeth C. Reed, MD University of Nebraska
More Information
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Responsible Party: Elizabeth Reed, MD, Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT00082641    
Other Study ID Numbers: 371-02
MCC-UNMC-37102
UNMC-37102
CDR0000354507 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2012-01019 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
First Posted: May 19, 2004    Key Record Dates
Results First Posted: December 12, 2018
Last Update Posted: February 5, 2019
Last Verified: January 2019
Keywords provided by Elizabeth Reed, MD, University of Nebraska:
stage IIIA breast cancer
stage IIIB breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases