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Paclitaxel, Cyclophosphamide, and Doxorubicin Followed by Autologous Dendritic Cells and Surgery With or Without Radiation Therapy and/or Hormone Therapy in Treating Women With Stage II or Stage III Breast Cancer

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2008

Sponsors and Collaborators: University of Nebraska
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00499083
  Purpose

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, cyclophosphamide, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Injecting the patient's dendritic cells directly into the tumor may stimulate the immune system and stop tumor cells from growing. Radiation therapy uses high-energy x-rays to kill tumor cells. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving combination chemotherapy together with autologous dendritic cells before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving radiation therapy and hormone therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects and how well giving paclitaxel together with cyclophosphamide and doxorubicin followed by autologous dendritic cells and surgery with or without radiation therapy and/or hormone therapy works in treating women with stage II or stage III breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Drug: tamoxifen citrate
Drug: therapeutic autologous lymphocytes
Procedure: aromatase inhibition therapy
Procedure: biopsy
Procedure: conventional surgery
Procedure: gene expression analysis
Procedure: immunoenzyme technique
Procedure: immunohistochemistry staining method
Procedure: laboratory biomarker analysis
Procedure: protein expression analysis
Procedure: radiation therapy
Procedure: reverse transcriptase-polymerase chain reaction
Phase II

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

ChemIDplus related topics:   Doxorubicin    Doxorubicin hydrochloride    Cyclophosphamide    Paclitaxel    Tamoxifen    Tamoxifen citrate    Citric acid    Sodium Citrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Neoadjuvant Intratumoral Injection of Dendritic Cells in Breast Cancer Translation of Biotechnology Into the Clinic

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Pathological complete response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory cell infiltration [ Designated as safety issue: No ]
  • Antibody-dependent cell-mediated cytotoxicity [ Designated as safety issue: Yes ]
  • Influence of tumor COX-2 and VEGF expression on dendritic cell-mediated tumor-specific immunity [ Designated as safety issue: No ]

Estimated Enrollment:   30
Study Start Date:   May 2006

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive breast cancer meeting the following criteria:

    • Primary tumor ≥ 3 cm by mammography, ultrasound, or palpation AND/OR palpable axillary lymph nodes > 1 cm
    • Survivin- and/or carcinoembryonic antigen-positive by IHC
    • Tumor must be localized by exam or ultrasound to allow tumor injection
    • No stage IV or metastatic disease
  • HER2/neu-negative tumor by IHC

    • If 2+ or in the indeterminate range, further testing of HER2/neu overexpression by fluorescent in situ hybridization (FISH) is required
  • Hormone receptor status known

PATIENT CHARACTERISTICS:

  • Female
  • Pre-, peri-, or postmenopausal
  • ECOG performance status 0-1
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for up to 6 months following completion of study therapy
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 times ULN
  • AST and ALT ≤ 1.5 times ULN
  • Creatinine < 1.5 times ULN
  • No active serious infections
  • No prior malignancy except adequately treated basal cell or squamous cell skin cancer, noninvasive carcinoma, or other cancer from which the patient has been disease free for 5 years
  • No comorbidity or condition that would interfere with study assessments and procedures or preclude study participation

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499083

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida     Recruiting
      Tampa, Florida, United States, 33612-9497
      Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese     800-456-7121     canceranswers@moffitt.org    
United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center     Recruiting
      Omaha, Nebraska, United States, 68198-6805
      Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ     800-999-5465        

Sponsors and Collaborators
University of Nebraska
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Elizabeth C. Reed, MD     University of Nebraska    
Principal Investigator:     Kenneth H. Cowan, MD, PhD     University of Nebraska    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000553127, UNMC-07206
First Received:   July 10, 2007
Last Updated:   September 11, 2008
ClinicalTrials.gov Identifier:   NCT00499083
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
stage II breast cancer  
stage IIIA breast cancer  
stage IIIB breast cancer  
stage IIIC breast cancer  

Study placed in the following topic categories:
Skin Diseases
Paclitaxel
Citric Acid
Breast Neoplasms
Cyclophosphamide
Tamoxifen
Doxorubicin
Breast Diseases

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Antibiotics, Antineoplastic
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Neoplasms by Site
Therapeutic Uses
Alkylating Agents
Estrogen Antagonists
Antineoplastic Agents, Hormonal
Mitosis Modulators
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on October 06, 2008




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