Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072111
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2003-11-04
Brief Title:
Anakinra in Treating Patients With Metastatic Cancer Expressing the Interleukin-1 Gene
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Anakinra Mediated Tumor Regression and Angiogenesis Inhibition in Subjects With Cancers Producing Interleukin-1
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-03-C-0281 | None | None | None |