Immunotherapy in Treating Patients With Metastatic Breast Cancer

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Biological: carcinoembryonic antigen RNA-pulsed DC cancer vaccine	Phase 1; Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	4 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	June 1998
Actual Primary Completion Date :	November 2002
Actual Study Completion Date :	November 2002

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: carcinoembryonic antigen RNA-pulsed DC cancer vaccine; carcinoembryonic antigen RNA-pulsed DC cancer vaccine	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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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) ]

Secondary Outcome Measures :

1. 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) ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

National Cancer Institute (NCI)

Investigators

Study Chair:	Herbert K. Lyerly, MD	Duke University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT00003432 History of Changes
Other Study ID Numbers:	2030; IRB 2030 ( Other Identifier: DUMC ); CDR0000066458 ( Other Identifier: NCI )
First Posted:	April 25, 2003
Last Update Posted:	November 6, 2013
Last Verified:	November 2013

Keywords provided by Duke University:

stage IV breast cancer

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases	Skin Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs