Status:
COMPLETED
Anakinra in Treating Patients With Metastatic Cancer Expressing the Interleukin-1 Gene
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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 p...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00072111
Start Date
September 1 2003
Last Update
April 30 2015
Active Locations (1)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182