NCT00003432

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1 breast-cancer

Timeline
Completed

Started Jun 1998

Typical duration for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 25, 2003

Completed
Last Updated

November 6, 2013

Status Verified

November 1, 2013

Enrollment Period

4.4 years

First QC Date

November 1, 1999

Last Update Submit

November 5, 2013

Conditions

Breast Cancer

Keywords

stage IV breast cancer

Outcome Measures

Primary Outcomes (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.

    Following administration of 4 IV vaccine doses (1 vaccine administered every 3 weeks)

Secondary Outcomes (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.

    Following administration of 4 IV vaccine doses (1 vaccine administered every 3 weeks)

Study Arms (1)

carcinoembryonic antigen RNA-pulsed DC cancer vaccine

EXPERIMENTAL

carcinoembryonic antigen RNA-pulsed DC cancer vaccine

Biological: carcinoembryonic antigen RNA-pulsed DC cancer vaccine

Interventions

carcinoembryonic antigen RNA-pulsed DC cancer vaccineBIOLOGICAL

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.

carcinoembryonic antigen RNA-pulsed DC cancer vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Herbert K. Lyerly, MD

    Duke University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 25, 2003

Study Start

June 1, 1998

Primary Completion

November 1, 2002

Study Completion

November 1, 2002

Last Updated

November 6, 2013

Record last verified: 2013-11

Locations

US(1)