Trastuzumab, Cyclophosphamide, and Vaccine Therapy in Treating Patients With High-Risk or Metastatic Breast Cancer

Summary

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. Giving trastuzumab together with cyclophosphamide and vaccine therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving trastuzumab together with cyclophosphamide and vaccine therapy in treating patients with high-risk or metastatic breast cancer.

Conditions

• Breast Cancer

Interventions

BIOLOGICAL

allogeneic GM-CSF-secreting breast cancer vaccine

Day 0 : Allogeneic GM-CSF-secreting Breast Cancer Vaccine administered as: 12 intradermal injections of a divided total dose of 5 x108 cells.

BIOLOGICAL

trastuzumab

Patient HAS received prior Trastuzumab within the last two weeks, give Trastuzumab 2 mg/kg weekly on Day -1 for 5 weeks. Patient has NOT received Trastuzumab within the last two weeks, give On Cycle 1, Day -1 ONLY, Loading dose 4 mg/kg

DRUG

cyclophosphamide

Cyclophosphamide 200mg/m2 IV in NS 100ml over 30 minutes on Day -1 ONLY. Note: there are no dose modifications for Cyclophosphamide.

OTHER

flow cytometry

Samples will be analyzed by flow cytometry using Cell Quest software

OTHER

immunoenzyme technique

OTHER

immunohistochemistry staining method

Measuring Immune Priming In Vivo By Vaccine Site Biopsies

OTHER

laboratory biomarker analysis

OTHER

pharmacological study

PROCEDURE

biopsy

skin biopsy to be performed on day 3 and day 7 for cycle 1 and 3 only

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  lead OTHER

Principal Investigators

• Leisha A. Emens, MD, PhD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-12-31

Primary Completion

2013-06-30

Completion

2013-06-30

Countries

• United States

Study Locations