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Biological Therapy in Treating Patients With Advanced Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Duke University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005956
  Purpose

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 Intervention Phase
Breast Cancer
Gastric Cancer
Ovarian Cancer
Drug: HER-2/neu intracellular domain protein
Drug: therapeutic autologous dendritic cells
Phase I

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Ovarian Cancer Stomach Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: 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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2000
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Menopausal status:

  • Not specified

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • Greater than 6 months

Hematopoietic:

  • WBC at least 3,000/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 hepatic disease, including viral hepatitis

Renal:

  • Creatinine less than 2.5 mg/dL

Cardiovascular:

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

Pulmonary:

  • No asthma or chronic obstructive pulmonary disease

Immunologic:

  • 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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No other concurrent immunotherapy

Chemotherapy:

  • 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)

Radiotherapy:

  • 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

Surgery:

  • At least 4 weeks since prior surgery and recovered

Other:

  • Concurrent bisphosphonates allowed
  • No prior hepatitis B immunization
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005956

Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Study Chair: Michael A. Morse, MD Duke University
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000067937, DUMC-1309-00-7R1, DUMC-1528-99-9, NCI-G00-1800
Study First Received: July 5, 2000
Last Updated: January 10, 2009
ClinicalTrials.gov Identifier: NCT00005956  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Digestive System Neoplasms
Skin Diseases
Gonadal Disorders
Gastrointestinal Diseases
Genital Neoplasms, Female
Endocrine System Diseases
Breast Neoplasms
Stomach cancer
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Genital Diseases, Female
Digestive System Diseases
Stomach Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Endocrinopathy
Breast Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on February 06, 2009