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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 (HER2+) Breast Cancer
Study Design
This is a Phase I/II non-randomized, single arm study designed to evaluate the safety of administering escalating doses of ex vivo expanded HER2 specific T cells to patients with advanced stage HER2+ breast cancer after in vivo priming with a HER2 specific vaccine.
Study Contact
Stephanie Parker | 866.932.8588 | E-Mail
Patient Population
  1. HER2-neu over-expressing
  2. Stage IV Breast Cancer
  3. Maximally treated without complete response
  4. Currently have measurable disease
Number of Patients: This study will accrue a maximum of 20 patients.
Study Treatments

  1. HER-2/neu peptide vaccines: 3 vaccines, given weekly (± 7 days)
  2. Leukapheresis 2 weeks (± 7 days) after final vaccine
  3. Cells take 24 days to grow. They can be grown immediately after leukapheresis, or frozen and grown later if patients wish.
  4. Cyclophosphamide infusion 24 hours before 1st T cell infusion
  5. T cell infusions: 3 infusions, 7-10 days apart
  6. Booster vaccines: 1, 2, and 4 months (each ± 7 days) after final T cell infusion
Long-Term Follow-Up

Every 3 months for first year after treatment, then every 4 months for second year after treatment (includes blood collection; may be done at primary physician’s office)
Patient Visits

  1. Total of 11 visits to Seattle
  2. 7 Follow-up visits, not required to be in Seattle
Treatment Information

Vaccine: Intradermal administration of a HER2 ICD peptide-based vaccine administered with a fixed dose of GM-CSF

T Cell Infusion: Autologous infusion after generation and expansion of HER-2/neu specific T-cells ex vivo
Other Procedures

  1. History & Physical
  2. Tetanus Vaccine
  3. Blood Tests and urinalysis
  4. Research blood tests
  5. Imaging studies (PET, CT, etc, as appropriate)
  6. Pre-medications associated with cyclophosphamide
  7. Chest x-ray
  8. MUGA or echocardiogram for patients receiving trastuzumab
  1. How safe are escalating doses of T cell infusions?
  2. How much can we boost immunity to HER2 after infusions of HER2-specific T cells?
  3. How long do increases in HER2-specific T cells persist after the T cell infusions and booster vaccines?
  4. Do we see CD4+ and CD8+ epitope spreading after adoptive T cell therapy?
  5. What are the anti-tumor effects of HER2-specific T cells in patients with advanced HER2+ breast cancer?
Start Date: October 2008
Study Location: University of Washington Medical Center | 1959 NE Pacific Street | Seattle, WA 98195
Current Enrollment: TBA
Related Publications
Generation of T cell immunity to the HER-2/neu protein after active immunization with HER-2/neu peptide-based vaccines
Disis ML, Gooley TA, Rinn K, Davis D, Piepkorn M, Cheever MA, Knutson KL, Schiffman K
J Clinical Oncology 20(11): 2624-32, 2002

Scientific Description
ClinicalTrials.gov Identifier: NCT00791037
Page last updated 01/26/2012

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