RWF_13-012

Phase I Study of Safety and Immunogenicity of ADU-623, a live-attenuated Listeria monocytogenes vaccine (ΔactA/ΔinlB) expressing EGFRvIII and NY-ESO-1, in Patients with Treated and Recurrent WHO Grade III/IV Astrocytomas

This is a study for patients with brain tumors called astrocytic tumors. The study will enroll patients who have received standard treatment. The study will test a vaccine called ADU-623. ADU-623 has not been tested in humans before, so the goal of this study is to see if ADU-623 can be given safely to brain cancer patients and what is the better dose to give patients among the three doses that planned to be tested. This study will also evaluate the length of time before patients' cancer worsens and if ADU-623 helps patients to live longer. The study will also measure the body's immune system response to ADU-623.

Key Eligibility:

• Patients with a pathologic diagnosis of WHO Grade III or Grade IV astrocytic tumors that have completed standard of care or with radiographic evidence of progression following standard of care.

• Tumor tissue blocks available to perform both EGFRvIII and NY-ESO-1 testing

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or Karnofsky Performance Status (KPS) 70-100

• Have a life expectancy of more than 12 weeks
Phase I
NCT01967758
Oncology
Brain
Marka Crittenden, M.D., Ph.D.
Earle A Chiles Research Institute (EACRI)
Chris Fountain
  • Oncology and Hematology Care Eastside
  • Providence Portland Medical Center