Interleukin-2 in Treating Patients With Mycosis Fungoides
RATIONALE: Interleukin-2 may stimulate a person's 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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase 1 Trial of Subcutaneous [SC]; Outpatient Interleukin-2 for Patients With Advanced Mycosis Fungoides [Stage IIb, III, IV]|
|Study Start Date:||February 1995|
|Study Completion Date:||July 2003|
|Primary Completion Date:||July 2003 (Final data collection date for primary outcome measure)|
- 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.
|United States, Washington|
|University of Washington Medical Center|
|Seattle, Washington, United States, 98195-6043|
|Study Chair:||John A. Thompson, MD||Seattle Cancer Care Alliance|