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

NCT00072111 | Completed Phase 1

• 2 other identifiers: CDR0000335469NCI-03-C-0281
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

anakinra BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Interventions

Interleukin 1 Receptor Antagonist Protein

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Steven K. Libutti, MD

  NCI - Surgery Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 4, 2003
• First Posted: November 6, 2003
• Study Start: September 1, 2003
• Last Updated: April 30, 2015

Record last verified: 2006-04

Locations

US (1)