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Anakinra in Treating Patients With Metastatic Cancer Expressing the Interleukin-1 Gene
This study has been completed.
First Received: November 4, 2003   Last Updated: February 6, 2009   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00072111
  Purpose

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Biological: anakinra
Phase I

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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 4 months

Hematopoietic

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

Hepatic

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

Renal

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

Other

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

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

Chemotherapy

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

Endocrine therapy

  • See Disease Characteristics
  • No concurrent steroids

Radiotherapy

  • 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

Surgery

  • See Disease Characteristics

Other

  • At least 30 days since prior antibiotic therapy for infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00072111

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Principal Investigator: Steven K. Libutti, MD NCI - Surgery Branch
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000335469, NCI-03-C-0281
Study First Received: November 4, 2003
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00072111     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Therapeutic Uses
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009