Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002687
Status:
COMPLETED
Last Update Posted:
2012-12-04
First Post:
1999-11-01
Brief Title:
Interleukin-2 in Treating Patients With Mycosis Fungoides
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Phase 1 Trial of Subcutaneous SC Outpatient Interleukin-2 for Patients With Advanced Mycosis Fungoides Stage IIb III IV
Status:
COMPLETED
Status Verified Date:
2012-11
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 Interleukin-2 may stimulate a persons white blood cells to kill cancer cells
PURPOSE Phase I trial to study the effectiveness of interleukin-2 in treating patients who have mycosis fungoides
PURPOSE Phase I trial to study the effectiveness of interleukin-2 in treating patients who have mycosis fungoides
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and toxicity of interleukin-2 in patients with stage IIB-IV mycosis fungoides
Determine the response rate of patients treated with this regimen
Determine the immunologic response to this regimen in peripheral blood leukocytes and serum of these patients
OUTLINE This is a dose escalation study
Patients receive interleukin-2 IL-2 subcutaneously on days 1-5 during weeks 1-3 and on days 1-3 and 5 during week 4 Treatment repeats every 4 weeks for 4 courses
Cohorts of 3-6 patients receive escalating doses of IL-2 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 3 of 6 patients experience dose-limiting toxicity Six additional patients receive IL-2 at 1 dose level preceding the MTD
Patients are followed at least 3 times during year 1 and then annually thereafter
PROJECTED ACCRUAL A total of 16-30 patients will be accrued for this study
Determine the maximum tolerated dose and toxicity of interleukin-2 in patients with stage IIB-IV mycosis fungoides
Determine the response rate of patients treated with this regimen
Determine the immunologic response to this regimen in peripheral blood leukocytes and serum of these patients
OUTLINE This is a dose escalation study
Patients receive interleukin-2 IL-2 subcutaneously on days 1-5 during weeks 1-3 and on days 1-3 and 5 during week 4 Treatment repeats every 4 weeks for 4 courses
Cohorts of 3-6 patients receive escalating doses of IL-2 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 3 of 6 patients experience dose-limiting toxicity Six additional patients receive IL-2 at 1 dose level preceding the MTD
Patients are followed at least 3 times during year 1 and then annually thereafter
PROJECTED ACCRUAL A total of 16-30 patients will be accrued for this study
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 |
|---|---|---|---|
| UW-24218-AE | None | None | None |
| NCI-V95-0758 | None | None | None |