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Breast Cancer

HER2 Vaccination and Adoptive T Cell Therapy (UW-6658)
Phase I/II Study of Adoptive T Cell Therapy Following In Vivo Priming With a HER-2/Neu (HER2) Intracellular Domain (ICD) Peptide-Based Vaccine in Patients With Advanced Stage HER2 Overexpressing Breast Cancer
Status Conditions Phase Study ID
Recruiting Breast Cancer Phase I/II UW-6658
NCT00791037
Summary

RATIONALE: Vaccines made from a person's white blood cells may help the body build an effective immune response to kill tumor cells that overexpress HER2.

PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy in treating patients with stage IV breast cancer.


Investigator
Lupe Salazar, MD
Location    
SCCA Breast Cancer Clinical Trials Program 800-804-8824 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of breast cancer

    • Stage IV disease

    • Previously treated disease

      • Maximally treated and has not achieved a complete remission
  • Not considered curable by conventional therapies
  • HER2 overexpression in the primary tumor or metastasis diagnosed by IHC of 2^+ or 3^+, or documented gene amplification by FISH analysis; if overexpression is 2^+ by IHC, then patients must have HER2 gene amplification documented by FISH
  • Stable or slowly progressive disease

  • Measurable disease, defined as stable disease, while receiving trastuzumab (Herceptin®) and/or hormonal therapy or bisphosphonates

    • Extraskeletal disease accurately measured in ≥ 1 dimension as ≥ 20 mm with conventional CT techniques or ≥ 10 mm with spiral CT scan
    • Skeletal or bone-only disease measurable by fludeoxyglucose F 18 positron emission tomography

  • History of brain metastases must have a stable head imaging study within 30 days of enrollment

    • Active brain metastases are not eligible
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • SWOG/Zubrod performance status 0-2
  • Menopausal status not specified
  • Life expectancy ≥ 6 months
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • ANC ≥ 1,000/mm³
  • Hemoglobin ≥ 10 mg/dL
  • Platelet count ≥ 100,000/mm³
  • Serum creatinine ≤ 2.0 mg/dL
  • Serum bilirubin ≤ 2.5 times upper limit of normal
  • No contraindication to receive granulocyte-macrophage colony-stimulating factor-based vaccine products
  • No history of disorders associated with immunosuppression (e.g., HIV)
  • No NYHA class III-IV heart failure
  • No symptomatic pericardial effusion
  • No unstable angina
  • Must have a baseline LVEF measured by MUGA or ECHO ≥ lower limit of normal (if on trastuzumab and/or lapatinib) within the past 6 months

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 3 weeks since prior immunosuppressive treatments (e.g., chemotherapy or systemic steroid therapy)

  • Concurrent trastuzumab and/or lapatinib, hormonal therapy, and/or bisphosphonates allowed

    • At least 7 days since prior chemotherapy and trastuzumab and/or lapatinib before cyclophosphamide administration
  • No concurrent enrollment in other treatment studies
Last Updated
February 02, 2011
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.