ECI301 and Radiation for Advanced or Metastatic Cancer

Summary

Background: \- ECI301 is a drug that may help make cancer cells more visible to the immune system after radiation. The drug may also help the immune system destroy the cancer at sites that have not received radiation therapy. Researchers want to study ECI301 in people with advanced cancer or cancer that has spread in the body (metastatic). Objectives: \- To test ECI301 with radiation therapy for advanced or metastatic cancer. Eligibility: \- People at least 18 years of age with either metastatic or advanced cancer that may benefit from radiation therapy. Design: * Participants will be screened with a medical history and physical exam. They will also have blood and urine tests, and imaging studies. * All participants will have radiation therapy 5 days a week for 2 weeks. * They will have different doses of ECI301 to test its safety and effectiveness. ECI301 will be given in a vein during the second week of radiation therapy. Frequent blood tests and imaging studies will monitor the treatment. * After participants have ECI301, tumor samples may be taken from the site that had radiation and another site that did not have radiation. * Follow-up visits will include blood tests and imaging studies.

Timeline

Start

2011-09-06

Primary completion

2013-04-24

Completion

2013-04-24

Outcome

Outcome not reported

Stopped: “A trial using ECI301 \& radiation was initiated in Japan in 2012. This tested the primary endpoint in a duplicate trial, thus the study was closed.”

Publications

• Background Friedman EJ. Immune modulation by ionizing radiation and its implications for cancer immunotherapy. Curr Pharm Des. 2002;8(19):1765-80. doi: 10.2174/1381612023394089.
• Background Sharp HJ, Wansley EK, Garnett CT, Chakraborty M, Camphausen K, Schlom J, Hodge JW. Synergistic antitumor activity of immune strategies combined with radiation. Front Biosci. 2007 Sep 1;12:4900-10. doi: 10.2741/2436.
• Background Maurer M, von Stebut E. Macrophage inflammatory protein-1. Int J Biochem Cell Biol. 2004 Oct;36(10):1882-6. doi: 10.1016/j.biocel.2003.10.019.

Drugs

Indications