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

Study Overview
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Brief Summary
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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.

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

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Biological: anakinra


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: anakinra|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific