Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Vaccine Therapy and GM-CSF in Treating Patients With Stage III or Stage IV Breast Cancer or Ovarian Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2009
Sponsors and Collaborators: University of Washington
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00436254
  Purpose

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 GM-CSF may be an effective treatment for breast cancer or ovarian cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy when given together with GM-CSF in treating patients with stage III or stage IV breast cancer or stage III or stage IV ovarian cancer.


Condition Intervention Phase
Breast Cancer
Ovarian Cancer
Drug: pNGVL3-hICD vaccine
Drug: sargramostim
Procedure: adjuvant therapy
Procedure: biopsy
Procedure: flow cytometry
Procedure: immunoenzyme technique
Procedure: immunologic technique
Procedure: protein expression analysis
Phase I

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Ovarian Cancer
Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor
U.S. FDA Resources
Study Type: Interventional
Study Design: 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

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

Primary Outcome Measures:
  • Safety as measured by NCI CTCAE v 3.0 [ Designated as safety issue: Yes ]
  • Immune response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of dose on immunologic response [ Designated as safety issue: No ]
  • Persistence of antigen expression at the injection site [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: October 2001
Estimated Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the safety of pNGVL3-hICD vaccine administered with sargramostim (GM-CSF) in patients with HER2/neu-overexpressing stage III or IV breast or ovarian cancer.
  • Determine if pNGVL3-hICD vaccine can elicit HER2-specific immune response.

Secondary

  • Determine if the dose of the vaccine affects immunologic responses.
  • Determine the persistence of antigen expression at the site of vaccination.

OUTLINE: This is a dose-escalation study of pNGVL3-hICD vaccine.

Patients receive pNGVL3-hICD vaccine and sargramostim (GM-CSF) intradermally once a month for 3 months in the absence of disease progression or unacceptable toxicity.

Cohorts of up to 22 patients receive escalating doses of pNGVL3-hICD vaccine until ≥ 1 patient experiences dose-limiting toxicity.

Patients undergo leukapheresis over 3-5 hours at 3 months after the last vaccination to obtain peripheral blood mononuclear cells for T-cell immunity studies. Patients also undergo skin biopsies at 1 and 6 months after the last vaccination to evaluate continued antigen expression.

Blood samples are obtained at baseline and then periodically during and after study treatment. Samples are examined for immune response by immunological laboratory methods. Flow cytometry and immunoenzyme techniques are also performed on samples.

After completion of study treatment, patients are followed periodically for up to 15 years.

PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of 1 of the following:

    • Breast cancer, meeting 1 of the following stage criteria:

      • Stage III disease
      • Stage IV disease, meeting all of the following criteria:

        • Metastasis in remission
        • Stable or healing bone disease with radiologic evaluation within the past 60 days including, but not limited to, bone scan, MRI, or positron emission tomography scan
        • No evidence of extraskeletal metastasis
    • Ovarian cancer, meeting 1 of the following stage criteria:

      • Stage III disease
      • Stage IV disease, meeting both of the following criteria:

        • In first complete remission
        • Normal and stable CA 125 with 2 sequential normal values taken ≥ 30 days apart, with the most recent value taken within the past 14 days
  • HER2-overexpressing disease

    • 3+ by immunohistochemistry (IHC) of the primary tumor or metastasis OR documented HER2 gene amplification by fluorescence in situ hybridization (FISH)
  • Completed treatment for primary disease
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Male or female
  • Menopausal status not specified
  • ECOG performance status (PS) OR Zubrod PS 0
  • Hematocrit ≥ 30%
  • Platelet count ≥ 100,000/mm³
  • WBC ≥ 3,000/mm³
  • Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min
  • Bilirubin < 1.5 mg/dL
  • SGOT < 2 times upper limit of normal
  • Antinuclear antibody, anti-double-stranded DNA, and complement C_3 normal
  • Recovered from major infections
  • No serious medical condition or illness that, in the opinion of the investigator, would preclude study participation or survival
  • No contraindication to receiving sargramostim (GM-CSF)-based vaccine products
  • No known history of cardiac disease

    • LVEF normal by MUGA or echocardiogram AND no decrease > 15% in subsequent MUGA (on or off trastuzumab)
    • No acute changes on ECG consistent with active ischemia or uncontrolled arrhythmia (off trastuzumab)
  • No known history of pulmonary disease other than controlled asthma
  • No active autoimmune disease
  • No active immunodeficiency disorder (e.g., HIV)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile male patients must use effective contraception
  • Female patients must be unable to bear children as a result of 1 of the following:

    • Permanent sterilization (e.g., tubal ligation)
    • Menopausal effects of chemotherapy
    • Natural menopausal effects
    • Surgery

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior surgical procedures
  • More than 1 month since prior cytotoxic chemotherapy or corticosteroids
  • No concurrent enrollment on other treatment clinical trials
  • No concurrent chemotherapy, steroids, or other immune modulators
  • Concurrent hormonal and bisphosphonate therapy allowed
  • Concurrent trastuzumab (Herceptin®) monotherapy allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436254

Locations
United States, Washington
University of Washington School of Medicine Recruiting
Seattle, Washington, United States, 98195
Contact: Clinical Trials Office - University of Washington School of Me     206-616-8289        
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Mary (Nora) L. Disis, MD University of Washington
  More Information

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

Study ID Numbers: CDR0000528923, UWASH-01-9773-D07
Study First Received: February 15, 2007
Last Updated: January 13, 2009
ClinicalTrials.gov Identifier: NCT00436254  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
stage III ovarian epithelial cancer
stage III ovarian germ cell tumor
stage IV ovarian epithelial cancer
stage IV ovarian germ cell tumor
ovarian sarcoma
ovarian stromal cancer

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Skin Diseases
Gonadal Disorders
Malignant mesenchymal tumor
Genital Neoplasms, Female
Breast Neoplasms
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Soft tissue sarcomas
Genital Diseases, Female
Sarcoma
Endocrinopathy
Breast Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 15, 2009