|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|
|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.|
|Stephanie Parker | 866.932.8588 | E-Mail|
|HER2 is an established tumor antigen in breast cancer. Indeed, patients with HER2 overexpressing breast cancers can be immunized against the protein. Data from a Phase I study of HER2 peptide based vaccines designed to elicit a CD4+ HER2 specific T cell response demonstrated a prolonged survival in the 38 Stage IV breast cancer patients who completed vaccinations. Furthermore, HER2 specific T cell lines can be readily expanded ex vivo after patients had been primed with in vivo immunization.
Therapeutic cancer vaccines are most likely to have greatest efficacy in the adjuvant setting as a means to prevent cancer relapse after optimal therapy. When cancer vaccines have been used to treat established disease there have been few clinical responses. Adoptive T cell therapy, however, has the potential to increase tumor specific T cell precursor frequencies to levels which cannot be achieved with immunization alone. Studies in a transgenic mouse model of neu mediated breast cancer demonstrate infusion of neu-specific CD4+ T cells elicited by peptide based vaccination can mediate an anti-tumor response in established disease states. Furthermore, preliminary results from a Phase I study of infusion of HER2 specific T cells generated in a patient who had been previously immunized with a HER2 vaccine indicates the approach may be safe and able to mediate an anti-tumor response.
This study will explore expanding HER2 specific T cells ex vivo after in vivo priming with a HER2 ICD peptide vaccine and the safety of infusion of these T cells in patients with advanced stage HER2+ breast cancer.
|Study Population / Indication|
|Patients with HER2+ Stage IV breast cancer who have been maximally treated and have not achieved a complete remission.|
|Number of Patients: This study will accrue a maximum of 20 patients.|
|Start Date: Oct 2008|
|Study Location: University of Washington Medical Center | 1959 NE Pacific Street | Seattle, WA 98195|
|Current Enrollment: TBA|
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
|ClinicalTrials.gov Identifier: NCT00791037|
Page last updated 01/31/2012