Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062049
Status:
COMPLETED
Last Update Posted:
2012-03-08
First Post:
2003-06-05
Brief Title:
Interleukin-7 in Treating Patients With Refractory Solid Tumors
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Study of Subcutaneous CYT 99 007 Interleukin-7 in Patients With Refractory Non Hematologic Malignancy
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Interleukin-7 may stimulate a persons white blood cells to kill tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of interleukin-7 in treating patients with refractory solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of interleukin-7 in treating patients with refractory solid tumors
Detailed Description:
OBJECTIVES
Determine the safety and dose-limiting toxicity of biologically active doses of interleukin-7 in patients with refractory solid tumors
Determine a range of biologically active doses of this drug in these patients
Determine the biological effects of this drug in these patients
Determine the pharmacokinetics and pharmacodynamics of this drug in these patients
Determine the antitumor effects of this drug in these patients
OUTLINE This is a multicenter dose-escalation study
Patients receive interleukin-7 IL-7 subcutaneously on days 0 2 4 6 8 10 12 and 14 for a total of 8 doses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of IL-7 until the maximum tolerated dose MTD and biologically active dose BAD are determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity The BAD is defined as the dose that produces a sustained 50 increase in CD3 count over the patients baseline without unacceptable toxicity
Patients are followed at 1 3 and 6 months and at 1 year after study completion
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 375-10 months
Determine the safety and dose-limiting toxicity of biologically active doses of interleukin-7 in patients with refractory solid tumors
Determine a range of biologically active doses of this drug in these patients
Determine the biological effects of this drug in these patients
Determine the pharmacokinetics and pharmacodynamics of this drug in these patients
Determine the antitumor effects of this drug in these patients
OUTLINE This is a multicenter dose-escalation study
Patients receive interleukin-7 IL-7 subcutaneously on days 0 2 4 6 8 10 12 and 14 for a total of 8 doses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of IL-7 until the maximum tolerated dose MTD and biologically active dose BAD are determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity The BAD is defined as the dose that produces a sustained 50 increase in CD3 count over the patients baseline without unacceptable toxicity
Patients are followed at 1 3 and 6 months and at 1 year after study completion
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 375-10 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-C-0152I | None | None | None |
| CDR0000304451 | None | None | None |