A Phase II Open-label Study of Subcutaneous CPG ODN (PF03512676) in Combination With Trastuzumab in Patients With Metastatic Breast Cancer
- To evaluate the progression-free survival of patients with HER2-overexpressing locally
advanced or metastatic breast cancer treated with trastuzumab (Herceptin®) and
- To determine if agatolimod sodium augments antibody-mediated cytoxicity (ADCC) against
trastuzumab-coated target cells by evaluating the ability of patient immune-effector
cells to conduct ADCC and produce interferon gamma.
OUTLINE: This is a multicenter study.
Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Patients also
receive agatolimod sodium subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15,
and 22 of all subsequent courses. Treatment repeats every 28 days in the absence of disease
progression or unacceptable toxicity.
Blood samples are collected periodically for correlative laboratory studies. Samples are
analyzed for antibody-mediated cytotoxicity (ADCC) by chromium-release assay; IFN-γ
production and quantification by flow cytometry and reverse transcriptase-polymerase chain
reaction (RT-PCR); and levels of cytokines (IFN-γ and TNF-α) by ELISA.
After completion of study therapy, patients are followed periodically.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine if PF-03512676 augments antibody mediated cytoxicity (ADCC)against trastuzumab-coated target cells in metastatic HER2 overexpressing breast cancer.
up to 18 weeks
Bhuvaneswari Ramaswamy, MD
Ohio State University
United States: Food and Drug Administration
|Ohio State University||Columbus, Ohio 43210|