Completed

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

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What is being tested

Data Collection

Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 2003
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2003Actual date on which the first participant was enrolled.

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.

Official TitlePhase I Study of Anakinra Mediated Tumor Regression and Angiogenesis Inhibition in Subjects With Cancers Producing Interleukin-1 
NCT00068016NCT00072111
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
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



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, United StatesSee the location

CompletedOne Study Center
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