search
Back to results

Immunotherapy in Treating Patients With Metastatic Breast Cancer

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
carcinoembryonic antigen RNA-pulsed DC cancer vaccine
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

carcinoembryonic antigen RNA-pulsed DC cancer vaccine

Arm Description

carcinoembryonic antigen RNA-pulsed DC cancer vaccine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Determine the clinical efficacy in terms of overall and recurrence free survival of immunotherapy with CEA RNA pulsed dendritic cells in this patients population.

Full Information

First Posted
November 1, 1999
Last Updated
November 5, 2013
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00003432
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
June 1998 (undefined)
Primary Completion Date
November 2002 (Actual)
Study Completion Date
November 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IV breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
carcinoembryonic antigen RNA-pulsed DC cancer vaccine
Arm Type
Experimental
Arm Description
carcinoembryonic antigen RNA-pulsed DC cancer vaccine
Intervention Type
Biological
Intervention Name(s)
carcinoembryonic antigen RNA-pulsed DC cancer vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert K. Lyerly, MD
Organizational Affiliation
Duke University
Official's Role
Study Chair
Facility Information:
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Immunotherapy in Treating Patients With Metastatic Breast Cancer

We'll reach out to this number within 24 hrs