Anakinra in Treating Patients With Metastatic Cancer Expressing the Interleukin-1 Gene
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|ClinicalTrials.gov Identifier: NCT00072111|
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : April 30, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Biological: anakinra||Phase 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 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Study of Anakinra Mediated Tumor Regression and Angiogenesis Inhibition in Subjects With Cancers Producing Interleukin-1|
|Study Start Date :||September 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072111
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Principal Investigator:||Steven K. Libutti, MD||NCI - Surgery Branch|