Biological Therapy in Treating Patients With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005956
Recruitment Status : Completed
First Posted : May 21, 2003
Last Update Posted : July 9, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

Brief Summary:

RATIONALE: A person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have advanced cancer that shows no signs of disease following treatment.

Condition or disease Intervention/treatment
Breast Cancer Gastric Cancer Ovarian Cancer Biological: HER-2/neu intracellular domain protein Biological: therapeutic autologous dendritic cells

Detailed Description:


  • Evaluate the immune response of patients with HER2/neu expressing advanced malignancies showing no evidence of disease after standard treatment when injected with HER2/neu intracellular domain protein pulsed autologous dendritic cells.
  • Assess time to recurrence in these patients.

OUTLINE: Autologous dendritic cells (DC) are pulsed with HER2/neu intracellular domain protein (ICD). The pulsed DC are administered subcutaneously (SQ) and intradermally, followed by autologous DC mixed with tetanus toxoid (TT) and autologous DC mixed with keyhole limpet hemocyanin (KLH) SQ and intradermally on day 1. HLA-A2 positive patients also receive autologous DC mixed with CMV pp65 peptide SQ and intradermally on day 1. Treatment continues every 3 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year or until disease progression.

PROJECTED ACCRUAL: A total of 6 patients will be accrued for this study over 6 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Active Immunotherapy With HER2/Neu Intracellular Domain (ICD) Protein-Pulsed, Autologous, Cultured Dendritic Cells in Patients With No Evidence of Disease After Standard Treatment for HER2/Neu Expressing Malignancies
Study Start Date : February 2000
Primary Completion Date : August 2001
Study Completion Date : July 2002

Intervention Details:
    Biological: HER-2/neu intracellular domain protein
    Other Name: HER2 ICD
    Biological: therapeutic autologous dendritic cells
    Other Name: DC

Primary Outcome Measures :
  1. Safety [ Time Frame: 12 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed advanced malignancy that expresses HER2/neu

    • Stage IIA breast cancer with more than 6 positive lymph nodes
    • Stage IIB, IIIA, or IIIB breast cancer
    • Stage III ovarian cancer
    • Lymph node positive gastric cancer
    • Metastatic tumor
  • No measurable or evaluable disease after standard treatment
  • No previously irradiated or newly diagnosed CNS metastases
  • Hormone receptor status:

    • Not specified



  • 18 and over

Menopausal status:

  • Not specified

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • Greater than 6 months


  • WBC at least 3,000/mm^3
  • Hemoglobin at least 9 mg/dL
  • Platelet count at least 100,000/mm^3


  • Bilirubin less than 2.0 mg/dL
  • No hepatic disease, including viral hepatitis


  • Creatinine less than 2.5 mg/dL


  • No New York Heart Association class III or IV heart disease


  • No asthma or chronic obstructive pulmonary disease


  • Must have positive intradermal delayed hypersensitivity test for at least 1 of the following:

    • Candida
    • Mumps
    • Tetanus
    • Trichophyton
    • Histoplasmin
  • No prior autoimmune disease including, but not limited to, the following:

    • Inflammatory bowel disease
    • Systemic lupus erythematosus
    • Ankylosing spondylitis
    • Scleroderma
    • Multiple sclerosis


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • Hepatitis B surface antigen and hepatitis C antibody negative
  • No other concurrent serious chronic or acute illness or infection (including urinary tract infection)
  • No known shellfish or iodine allergy
  • No other prior or concurrent malignancy except for nonmelanoma skin cancer, cervical cancer, or controlled superficial bladder cancer
  • No medical or psychological condition that may preclude study


Biologic therapy:

  • No other concurrent immunotherapy


  • At least 4 weeks since prior chemotherapy and recovered
  • No concurrent chemotherapy

Endocrine therapy:

  • Concurrent hormonal therapy allowed (tamoxifen, raloxifene, toremifene, and all aromatase inhibitors)
  • At least 4 weeks since prior steroid or immunosuppressive therapy (e.g, azathioprine or cyclosporine)


  • Prior radiotherapy allowed except to cranium
  • At least 4 weeks since prior radiotherapy and recovered
  • At least 12 weeks since prior strontium chloride Sr 89
  • No concurrent radiotherapy


  • At least 4 weeks since prior surgery and recovered


  • Concurrent bisphosphonates allowed
  • No prior hepatitis B immunization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005956

United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
Study Chair: Michael A. Morse, MD Duke Cancer Institute

Publications of Results:
Responsible Party: Duke University Identifier: NCT00005956     History of Changes
Other Study ID Numbers: 1309
6542 ( Other Identifier: FDA )
1528 ( Other Identifier: DUMC IRB )
CDR0000067937 ( Other Identifier: NCI )
First Posted: May 21, 2003    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: March 2013

Keywords provided by Duke University:
stage II breast cancer
stage IV breast cancer
stage IIIA breast cancer
stage II gastric cancer
stage III gastric cancer
stage IV gastric cancer
stage IIIB breast cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer

Additional relevant MeSH terms:
Breast Neoplasms
Stomach Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases