Phase I Study of Anakinra Mediated Tumor Regression and Angiogenesis Inhibition in Subjects With Cancers Producing Interleukin-1

OBJECTIVES:

Primary

• Determine the maximum tolerated dose and dose-limiting toxicity of anakinra in patients with metastatic cancer expressing the interleukin-1 gene.
• Determine the steady state pharmacokinetics of this drug in these patients.

Secondary

• Determine the antitumor efficacy of this drug in these patients.
• Determine gene expression changes in tumor biopsies and circulating leukocyte and cytokine levels in these patients before and after treatment with this drug.