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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Herbert K. Lyerly, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke University

Authority:

United States: Federal Government

Study ID:

CDR0000066458

NCT ID:

NCT00003432

Start Date:

June 1998

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • Breast Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710