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

April 29, 2015 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Registration Dates

First Submitted

November 4, 2003

First Submitted That Met QC Criteria

November 5, 2003

First Posted (Estimate)

November 6, 2003

Study Record Updates

Last Update Posted (Estimate)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 29, 2015

Last Verified

April 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000335469
  • NCI-03-C-0281

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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