Interleukin-2 in Treating Patients With Mycosis Fungoides or Sezary Syndrome
RATIONALE: Interleukin-2 may stimulate a person's 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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Trial of Subcutaneous Injections of Interleukin-2 for the Treatment of Mycosis Fungoides or the Sezary Syndrome|
|Study Start Date:||April 1997|
|Study Completion Date:||January 2002|
|Primary Completion Date:||January 2002 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005788
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Study Chair:||Timothy M. Kuzel, MD||Robert H. Lurie Cancer Center|