Biological Therapy in Treating Patients With Advanced Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00005956
First received: July 5, 2000
Last updated: July 7, 2014
Last verified: March 2013
  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
Breast Cancer
Gastric Cancer
Ovarian Cancer
Biological: HER-2/neu intracellular domain protein
Biological: therapeutic autologous dendritic cells

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    safety


Enrollment: 3
Study Start Date: February 2000
Study Completion Date: July 2002
Primary Completion Date: August 2001 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: HER-2/neu intracellular domain protein
    Other Name: HER2 ICD
    Biological: therapeutic autologous dendritic cells
    Other Name: DC
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Cancer Institute
  More Information

Additional Information:
Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00005956     History of Changes
Other Study ID Numbers: 1309, 6542, 1528, CDR0000067937
Study First Received: July 5, 2000
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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
Ovarian Neoplasms
Stomach Neoplasms
Adnexal Diseases
Breast Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Skin Diseases
Stomach Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014