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Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2 Positive Stage III-IV Breast Cancer or Ovarian Cancer

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington Identifier:
First received: February 15, 2007
Last updated: May 2, 2016
Last verified: May 2016
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy together with sargramostim may be an effective treatment for breast cancer and ovarian cancer. PURPOSE: This phase I trial is studying the side effects and identifying the best dose of vaccine therapy when given together with sargramostim in treating patients with stage III-IV breast cancer or ovarian cancer.

Condition Intervention Phase
HER2-positive Breast Cancer
Stage III Ovarian Epithelial Cancer
Stage III Ovarian Germ Cell Tumor
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Stage IV Ovarian Epithelial Cancer
Stage IV Ovarian Germ Cell Tumor
Biological: pNGVL3-hICD vaccine
Biological: sargramostim
Other: flow cytometry
Other: immunologic technique
Other: immunoenzyme technique
Genetic: protein expression analysis
Procedure: biopsy
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of a DNA Plasmid Based Vaccine Encoding the HER-2/Neu Intracellular Domain in Subjects With HER-2/Neu (HER2) Overexpressing Tumors

Resource links provided by NLM:

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Safety as measured by NCI CTCAE v 3.0 [ Time Frame: From baseline ]
  • Immune response [ Time Frame: From baseline ]

Secondary Outcome Measures:
  • Impact of dose on immunologic response [ Time Frame: From baseline to month 15 ]
  • Persistence of DNA at the injection site [ Time Frame: At 1 and 6 months after last vaccination ]

Estimated Enrollment: 66
Study Start Date: October 2001
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive pNGVL3-hICD vaccine admixed with GM-CSF intradermally once a month for 3 months in the absence of disease progression or unacceptable toxicity.
Biological: pNGVL3-hICD vaccine
Plasmid-based DNA vaccine, given intradermally
Biological: sargramostim
Given intradermally
Other Names:
  • GM-CSF
  • granulocyte macrophage colony-stimulating factor
  • Leukine
  • Prokine
  • rhu GM-CFS
Other: flow cytometry
Correlative studies
Other: immunologic technique
Correlative studies
Other Names:
  • immunological laboratory methods
  • laboratory methods, immunological
Other: immunoenzyme technique
Undergo ELIspot (correlative studies)
Other Name: immunoenzyme techniques
Genetic: protein expression analysis
Undergo ELISA (correlative studies)
Procedure: biopsy
Undergo punch biopsy (correlative studies)
Other Name: biopsies

Detailed Description:
PRIMARY OBJECTIVES: I. To determine the safety of intradermal administration of 3 doses of a plasmid-based DNA vaccine encoding the ICD of HER2 administered with a fixed dose of GM-CSF. II. To determine whether a plasmid DNA vaccine encoding the ICD of HER2 can elicit HER2 specific immune responses. SECONDARY OBJECTIVES: I. To determine if the dose of the plasmid-based DNA vaccine effects immunologic responses. II. To determine the persistence of DNA at the site of vaccination. OUTLINE: This is a dose-escalation study of a plasmid-based DNA (pNGVL3-hICD) vaccine. Patients receive pNGVL3-hICD vaccine admixed with GM-CSF intradermally once a month for 3 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for up to 15 years with primary physicians.

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

Inclusion Criteria:

  • Breast cancer: stage III or stage IV breast cancer with metastasis in remission and defined as NED (no evidence of disease); stable or healing bone disease by radiologic evaluation which may include, but is not limited to, bone scan, MRI, or PET scan documented within 90 days of enrollment to study and NED status for extraskeletal metastasis
  • Ovarian cancer: stage III or stage IV ovarian cancer in first complete remission with a normal AND stable CA-125; thus, two sequential normal CA-125 values will need to be documented; a minimum of 30 days between 2 sequential CA-125 values; the most recent will be within 2 weeks of enrollment into study
  • HER2 overexpression by immunohistochemistry (IHC) of 2+ or 3+ in their primary tumor or metastasis, and if overexpression is 2+ by IHC or in the absence of IHC, then patients must have documentation of HER2 gene amplification by FISH
  • Eligible subjects must have completed appropriate treatment for their primary disease and be off cytotoxic chemotherapy and corticosteroids for at least 1 month prior to enrollment; patients with stage III/IV breast cancer who have completed chemotherapy and are continued on trastuzumab monotherapy are eligible; hormonal and bisphosphanate therapies are allowed
  • Subjects must have a Performance Status Score (Zubrod/ECOG Scale) = 0
  • All subjects must no longer be able to bear children
  • Hematocrit >= 30
  • Platelet count >= 100,000
  • WBC >= 3,000/ul
  • Creatinine =< 2.0 or creatinine clearance >= 60 ml/minute
  • Serum bilirubin < 1.5 mg/dl
  • SGOT < 2 x ULN
  • Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment or survival
  • Normal ANA, anti-dsDNA and C3
  • Patients on trastuzumab monotherapy must have adequate cardiac function as demonstrated by normal ejection fraction (EF) of MUGA scan or echocardiogram

Exclusion Criteria:

  • Subjects cannot be simultaneously enrolled on other treatment studies
  • Any contraindication to receiving GM-CSF based vaccine products
  • Prior known history of cardiac disease, specifically restrictive cardiomyopathy, unstable angina within the last 6 months prior to enrollment, New York Heart Association functional class III-IV heart or symptomatic pericardial effusion
  • Prior known history of pulmonary disease other than controlled asthma
  • Active autoimmune disease
  • Subjects cannot have active immunodeficiency disorder, e.g., HIV
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Please refer to this study by its identifier: NCT00436254

United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Mary L. Disis Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

Responsible Party: University of Washington Identifier: NCT00436254     History of Changes
Obsolete Identifiers: NCT00194662
Other Study ID Numbers: 6532
Study First Received: February 15, 2007
Last Updated: May 2, 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017