Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005788
Status:
TERMINATED
Last Update Posted:
2012-06-06
First Post:
2000-06-02
Brief Title:
Interleukin-2 in Treating Patients With Mycosis Fungoides or Sezary Syndrome
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase II Trial of Subcutaneous Injections of Interleukin-2 for the Treatment of Mycosis Fungoides or the Sezary Syndrome
Status:
TERMINATED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lowinadequate rate of accrual
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 lymphoma cells
PURPOSE Phase II trial to study the effectiveness of interleukin-2 in treating patients who have mycosis fungoides or Sezary syndrome
PURPOSE Phase II trial to study the effectiveness of interleukin-2 in treating patients who have mycosis fungoides or Sezary syndrome
Detailed Description:
OBJECTIVES
Determine the response rate in patients with mycosis fungoides or Sezary syndrome treated with interleukin-2 IL-2
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive interleukin-2 subcutaneously for 4 consecutive days a week for 6 consecutive weeks Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity Patients who achieve complete response or stable disease continue treatment for 2 courses past best response Patients who demonstrate a persistent partial response continue treatment in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for survival
PROJECTED ACCRUAL A total of 15-35 patients will be accrued for this study
Determine the response rate in patients with mycosis fungoides or Sezary syndrome treated with interleukin-2 IL-2
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive interleukin-2 subcutaneously for 4 consecutive days a week for 6 consecutive weeks Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity Patients who achieve complete response or stable disease continue treatment for 2 courses past best response Patients who demonstrate a persistent partial response continue treatment in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for survival
PROJECTED ACCRUAL A total of 15-35 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 |
|---|---|---|---|
| NCI-G00-1735 | None | None | None |
| NU-96H7 | None | None | None |