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


Phase 1/Phase 2
19 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and toxicity

Outcome Time Frame:

1 week after each vaccine dose.

Safety Issue:

Yes

Principal Investigator

Elizabeth C. Reed, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Nebraska

Authority:

United States: Food and Drug Administration

Study ID:

371-02

NCT ID:

NCT00082641

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms

Name

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680