Interleukin-2 in Treating Patients With Mycosis Fungoides
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|ClinicalTrials.gov Identifier: NCT00002687|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 4, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: aldesleukin||Phase 1|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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|
|Actual Primary Completion Date :||July 2003|
|Actual Study Completion Date :||July 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002687
|United States, Washington|
|University of Washington Medical Center|
|Seattle, Washington, United States, 98195-6043|
|Study Chair:||John A. Thompson, MD||Seattle Cancer Care Alliance|