Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Active 19 and over NCI MCC-UNMC-37102 UNMC-37102, NCT00082641

Special Category: NCI Avon award trial

Objectives

1. 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.
2. Determine the immune response, in terms of humoral and cellular response, in patients treated with these regimens.
3. Determine antigen-specific immune responses in patients treated with these regimens.

Entry 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

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

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/mm³
• Platelet count > 100,000/mm³

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

Expected Enrollment

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

Outcomes

Safety and toxicity
Immune response
Importance of vaccine timing on antigen-specific immune responses

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.

Trial Contact Information

Trial Lead Organizations

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Elizabeth Reed, MD, Protocol chair		Ph: 402-559-5388 Email: ereed@unmc.edu

U.S.A.
Nebraska
	Omaha
	UNMC Eppley Cancer Center at the University of Nebraska Medical Center
		Clinical Trials Office - UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Ph:  800-999-5465

Registry Information
Official Title		1) Adenovirus p53 Infected DC Vaccine For Breast Cancer, 2) Translation of Biotechnology into the Clinic
Trial Start Date		2004-01-01
Trial Completion Date		2012-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00082641
Date Submitted to PDQ		2004-01-22
Information Last Verified		2006-09-20
NCI Grant/Contract Number		CA76292, CA36727

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