Suspended

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

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What is being tested

carcinoembryonic antigen RNA-pulsed DC cancer vaccine

Biological
Who is being recruted

Breast Diseases+3

+ Neoplasms

+ Neoplasms by Site

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: June 1998
See protocol details

Summary

Principal SponsorDuke University
Last updated: November 6, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00003432
Principal SponsorDuke University
Last updated: November 6, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

4 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast Neoplasms

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
carcinoembryonic antigen RNA-pulsed DC cancer vaccine

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Duke Comprehensive Cancer Center

Durham, United StatesOpen Duke Comprehensive Cancer Center in Google Maps
SuspendedOne Study Center