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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00072111
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : April 30, 2015
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Biological: anakinra Phase 1

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Anakinra

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of metastatic cancer
  • Measurable disease

    • Able to be percutaneously biopsied with minimum morbidity on protocol NCI-99-C-0128
  • Tumor expression of interleukin-1 by biopsy
  • Progressive disease during prior standard first-line chemotherapy OR refused standard first-line chemotherapy
  • No active intracranial or leptomeningeal metastases

    • Prior radiotherapy to or resection of intracranial metastatic disease allowed provided there is no evidence of active disease on MRI or CT scan for the past month AND there is no requirement for concurrent anticonvulsant or steroid medications



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 4 months


  • Platelet count greater than 75,000/mm^3
  • Absolute neutrophil count greater than 1,500/mm^3


  • PT within 2 seconds of the upper limit of normal
  • Bilirubin less than 1.5 mg/dL


  • Creatinine no greater than 1.6 mg/dL OR
  • Creatinine clearance greater than 30 mL/min


  • Not pregnant or nursing
  • Negative pregnancy test
  • No allergy to proteins made from bacteria
  • No active infection
  • HIV negative


Biologic therapy

  • More than 30 days since prior biologic therapy
  • No concurrent systemic immune modulators


  • See Disease Characteristics
  • More than 30 days since prior chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • No concurrent steroids


  • See Disease Characteristics
  • More than 14 days since prior localized radiotherapy to non-target lesions and recovered
  • More than 30 days since other prior radiotherapy


  • See Disease Characteristics


  • At least 30 days since prior antibiotic therapy for infection

Information from the National Library of Medicine

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 identifier (NCT number): NCT00072111

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United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: Steven K. Libutti, MD NCI - Surgery Branch
Layout table for additonal information Identifier: NCT00072111    
Obsolete Identifiers: NCT00068016
Other Study ID Numbers: CDR0000335469
First Posted: November 6, 2003    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: April 2006
Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents