Phase I/II Study of Stereotactic Body Radiation Therapy to Metastatic Lesions in the Liver or Lung in Combination With Monoclonal Antibody to OX40 in Patients With Progressive Metastatic Breast Cancer After Systemic Therapy.
This is a phase I/II study to determine the maximum tolerated dose of stereotactic body
radiation given with anti-OX40. Three different dose levels of radiation will be tested.
All patients will receive three doses of anti-OX40 given over a 60 minute IV infusion. Up to
18 patients will be treated during the dose escalation phase, and an additional 20 at the
maximum tolerated dose.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in blood tests, overall health or symptoms.
Patients will have radiation therapy and anti-OX40 on Day 1. Patients return to clinic on Days 2, 3, 5, 8, 15, 29 and 36 for blood tests and adverse event evaluations. Changes in blood tests that may represent a dose limiting toxicity will be evaluated. Changes in overall health or symptoms that may represent a dose-limiting drug side effect will be evaluated.
Marka Crittenden, MD
Earle A Chiles Research Institute at Providence Portland Medical Center
United States: Food and Drug Administration
|Providence Portland Medical Center||Portland, Oregon 97213-3635|