Number: 201012844 Principal Investigator: Zoberi, Imran
Title: A Phase I/II Study Evaluating the Maximum Tolerated Dose, BioequivalencePharmacokinetics, Safety, and Efficacy of Hyperthermia and Thermodox (Lyso-Thermosensitive Liposomal Doxorubicin) in Patients with Local-Regional Recurrent Breast Cancer
Phase: I/II Disease Site: Breast, Female
Participating Site(s):
Main Campus
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The purpose of this research study is to evaluate the effects of ThermoDox® in combination with therapeutic heating of the chest wall in the treatment of recurrent regional breast cancer. The United States Food and Drug Administration has approved therapeutic heat for the treatment of breast cancer.

The main purpose of this study is to find out if adding ThermoDox® to therapeutic heat will increase how long the breast cancer stays away after treatment. In this study, we will also examine the safety of ThermoDox®. Your own doctor has determined that you could be treated with a procedure called mild hyperthermia (therapeutic heat) in combination with a research drug, ThermoDox®. Mild hyperthermia is a system that delivers therapeutic heat to certain surface or subsurface malignant (cancerous) tumors in order to destroy them. ThermoDox® is an investigational drug not approved by the Food and Drug Administration (FDA) that is activated when it passes through a part of the body that has been warmed by therapeutic heat.
More Information:
Celsion-Hyperthermia and Thermodox
Internal Protocol Documents (requires Siteman administrative database password)