Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Durham, North Carolina 27710


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

2030


NCT ID:

NCT00003432


Secondary ID:

IRB 2030


Study Acronym:


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


Overall Status:

Terminated


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Duke University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:

low accrual


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Interventio


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

4


Enrollment Type:

Actual


Overall Contact Information

Official Name:Herbert K. Lyerly, MD
Study Chair
Duke University

Study Dates

Start Date:June 1998
Completion Date:November 2002
Completion Type:Actual
Primary Completion Date:November 2002
Primary Completion Type:Actual
Verification Date:November 2013
Last Changed Date:November 5, 2013
First Received Date:November 1, 1999

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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)
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:carcinoembryonic antigen RNA-pulsed DC cancer vacc
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.
Arm Name:carcinoembryonic antigen RNA-pulsed DC cancer vacc

Study Arms

Study Arm Type:Experimental
Arm Name:carcinoembryonic antigen RNA-pulsed DC cancer vaccine
Description:carcinoembryonic antigen RNA-pulsed DC cancer vaccine

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Duke University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.