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Immunotherapy in Treating Patients With Metastatic 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: NCT00003432
Recruitment Status : Terminated (low accrual)
First Posted : April 25, 2003
Last Update Posted : November 6, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE April 25, 2003
Last Update Posted Date November 6, 2013
Study Start Date  ICMJE June 1998
Actual Primary Completion Date November 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2013)
Evaluate the ability of active immunotherapy with carcinoembryonic antigen (CEA) RNA pulsed dendritic cells to induce CEA specific T cells in patients with metastatic breast cancer in complete remission following peripheral blood stem cell transplant. [ Time Frame: Following administration of 4 IV vaccine doses (1 vaccine administered every 3 weeks) ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2013)
Determine the clinical efficacy in terms of overall and recurrence free survival of immunotherapy with CEA RNA pulsed dendritic cells in this patients population. [ Time Frame: Following administration of 4 IV vaccine doses (1 vaccine administered every 3 weeks) ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunotherapy in Treating Patients With Metastatic Breast Cancer
Official Title  ICMJE A Phase I/II Study of Active Immunotherapy With Carcinoembryonic Antigen RNA-Pulsed, Autologous Cultured Dendritic Cells for Patients With Breast Cancer Who Achieve a Complete Response After High Dose Chemotherapy and Stem Cell Support
Brief Summary

RATIONALE: Immunotherapy using CEA-treated white blood cells may help a person's body build an immune response to and kill their tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of immunotherapy with CEA-treated white blood cells in treating patients with metastatic breast cancer who have achieved a partial or complete response after chemotherapy and peripheral stem cell transplantation.

Detailed Description

OBJECTIVES:

  • Evaluate the ability of active immunotherapy with carcinoembryonic antigen (CEA) RNA pulsed dendritic cells to induce CEA specific T cells in patients with metastatic breast cancer in complete remission following peripheral blood stem cell transplant.
  • Determine the clinical efficacy in terms of overall and recurrence free survival of immunotherapy with CEA RNA pulsed dendritic cells in this patients population.

OUTLINE: Dendritic cells are taken from the leukapheresis product obtained during the peripheral blood stem cell transplant procedure performed prior to treatment on this study. The dendritic cells are pulsed with carcinoembryonic antigen (CEA) RNA. Approximately 60-90 days after the peripheral blood stem cell transplant, patients receive CEA RNA pulsed dendritic cells IV every 3 weeks for a total of 4 doses. Patients undergo a second leukopheresis after the last dose of immunotherapy to obtain specimens for immunologic tests.

Patients are followed every 3 months for the first year and annually thereafter.

PROJECTED ACCRUAL: A total of 14-26 patients will be accrued for this study within 2 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Biological: carcinoembryonic antigen RNA-pulsed DC cancer vaccine
Approximately 60-90 days after the peripheral blood stem cell transplant, patients receive CEA RNA pulsed dendritic cells IV every 3 weeks for a total of 4 doses.
Study Arms  ICMJE Experimental: carcinoembryonic antigen RNA-pulsed DC cancer vaccine
carcinoembryonic antigen RNA-pulsed DC cancer vaccine
Intervention: Biological: carcinoembryonic antigen RNA-pulsed DC cancer vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 5, 2013)
4
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2002
Actual Primary Completion Date November 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic breast cancer that expresses carcinoembryonic antigen (CEA)

    • At least 25% of the tumor cells must stain positive for CEA with at least moderate intensity
  • Must have achieved either partial response or complete response after high dose chemotherapy and peripheral blood stem cell transplant
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Menopausal status:

  • Not specified

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Greater than 6 months

Hematopoietic:

  • Absolute neutrophil count at least 1000/mm^3
  • Absolute lymphocyte count at least 1000/mm^3
  • Hemoglobin at least 9 mg/dL
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin less than 2.0 mg/dL
  • No serious ongoing chronic or acute hepatic disease

Renal:

  • Creatinine less than 2.5 mg/dL

Cardiovascular:

  • No serious ongoing chronic or acute cardiac disease (New York Heart Association class III or IV)

Pulmonary:

  • No serious ongoing chronic or acute pulmonary illness such as asthma, chronic obstructive pulmonary disease, or radiation or drug induced pneumonitis

Other:

  • No other prior or concurrent malignancy except nonmelanoma skin cancer or controlled superficial bladder cancer within the past 5 years
  • No history of autoimmune disease such as inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis
  • No inflammatory bowel condition such as active infectious enteritis or eosinophilic enteritis
  • No active acute or chronic infection such as urinary tract infection, HIV, or viral hepatitis
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No concurrent immunotherapy

Chemotherapy:

  • See Disease Characteristics
  • No concurrent chemotherapy

Endocrine therapy:

  • At least 4 weeks since steroids
  • No concurrent steroid therapy

Radiotherapy:

  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • No concurrent immunosuppressive agents such as azathioprine or cyclosporine A
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003432
Other Study ID Numbers  ICMJE 2030
IRB 2030 ( Other Identifier: DUMC )
CDR0000066458 ( Other Identifier: NCI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Duke University
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Duke University
Original Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Herbert K. Lyerly, MD Duke University
PRS Account Duke University
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP