Immunotherapy in Treating Patients With Metastatic Breast Cancer

• ClinicalTrials.gov Identifier: NCT00003432
• Recruitment Status: Terminated
• First Posted: April 25, 2003
• Last Update Posted: November 6, 2013
• Sponsor: Duke University
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Duke University

Tracking Information

• First Submitted Date: November 1, 1999
• First Posted Date: April 25, 2003
• Last Update Posted Date: November 6, 2013
• Study Start Date: June 1998
• Actual Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Not Provided
• Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Immunotherapy in Treating Patients With Metastatic Breast Cancer
• 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

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: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Breast Cancer

Intervention

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

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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 5, 2013): 4
• Original Enrollment: Not Provided
• Actual Study Completion Date: November 2002
• Actual Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00003432
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Duke University
• Original Responsible Party: Not Provided
• Current Study Sponsor: Duke University
• Original Study Sponsor: National Cancer Institute (NCI)
• Collaborators: National Cancer Institute (NCI)

Investigators

• Study Chair: Herbert K. Lyerly, MD; Duke University

• PRS Account: Duke University
• Verification Date: November 2013