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Title
A Phase I Study of Infusion of HER-2/neu (HER2) Specific T Cells in Patients with Advanced Stage HER-2/neu Expressing Cancers who have Received a HER-2/neu Vaccine
 
Study Design
Expanding HER2 specific T cells ex vivo and administering these cells to patients in escalating doses.
 
Study Contact
Nicole Bates | 866.932.8588 | E-Mail
 
Patient Population
  1. Must be pre-immunized with a HER2-specific vaccine through a vaccine protocol (Approved by UW)
  2. HER2-neu overexpressing disease
  3. Progressive metastatic breast, ovarian, or non-small cell lung cancer
  4. Not considered curable by conventional therapies, including trastuzumab
  5. Measurable extraskeletal disease
Number of Patients: This study will accrue a maximum of 10 patients. 2 Arms with 5 patients per Arm.
 
Patients Visits

  1. First visit to collect lymphocytes & consent for study
  2. 3 infusions on Days 1, 10 & 20
  3. Follow-up visit on Day 40
  4. Blood draw 1 month post infusion #3
  5. Blood draw every 2 months for the 1st year
Other Procedures

  1. CT Scans
  2. Chemotherapy pre-meds
  3. Low dose cyclophosphamide (Cytoxan) to deplete T-regs
  4. Possible MUGA (if not done w/in 30 days of T-cell infusion
Objectives
Primary:
  1. Feasibility of HER2 T cells expansion
  2. Toxicity associated with HER2 T-cell infusion
Secondary:
  1. Potential anti-tumor effects of HER2 specific T cells
  2. To determine the persistence of DNA at the site of vaccination
  3. Persistence of immune response
Start Date: June 2003
 
Study Location: University of Washington Medical Center | 1959 NE Pacific Street | Seattle, WA 98195
 
Current Enrollment: 50%
 
Related Publications
Tumor antigen-specific T-cell expansion is greatly facilitated by in vivo priming
Dang Y, Knutson KL, Goodell V, dela Rosa C, Salazar LG, Higgins D, Childs J, Disis ML
Clin Cancer Research 13(6):1883-91, 2007
 
Scientific Description
 
ClinicalTrials.gov Identifier: NCT00228358
 
Page last updated 4/27/09