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


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Steven K. Libutti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI - Surgery Branch

Authority:

United States: Federal Government

Study ID:

CDR0000335469

NCT ID:

NCT00072111

Start Date:

September 2003

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182