Phase I Study of Anakinra Mediated Tumor Regression and Angiogenesis Inhibition in Subjects With Cancers Producing Interleukin-1
- 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.
- 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.
OUTLINE: This is a dose-escalation study.
Patients receive anakinra subcutaneously 1-3 times daily on days 1-28. Treatment repeats
every 28 days for up to 6 courses in the absence of disease progression or unacceptable
Cohorts of 3-6 patients receive escalating doses of anakinra until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 6
patients are treated at that dose.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1-2 years.
Primary Purpose: Treatment
Steven K. Libutti, MD
NCI - Surgery Branch
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|