Spots Global Cancer Trial Database for Anakinra in Treating Patients With Metastatic Cancer Expressing the Interleukin-1 Gene

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Anakinra in Treating Patients With Metastatic Cancer Expressing the Interleukin-1 Gene

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

Study ID: NCT00072111

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

anakinra

Study Description

Brief Summary: RATIONALE: Biological therapies, such as anakinra, may interfere with the growth of the tumor cells and slow the growth of metastatic tumors that express the interleukin-1 gene. PURPOSE: This phase I trial is studying the side effects and best dose of anakinra in treating patients with metastatic cancer that expresses the interleukin-1 gene.

Detailed Description: 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. 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 toxicity. 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.