Phase II Trial of Subcutaneous Injections of Interleukin-2 for the Treatment of Mycosis Fungoides or the Sezary Syndrome
Phase II Trial of Subcutaneous Injections of Interleukin-2 for the Treatment of Mycosis Fungoides or the 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.
OBJECTIVES:
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.
DISEASE CHARACTERISTICS:
Histologically proven mycosis fungoides or Sezary syndrome
Measurable disease with 1 or more indicator lesions
At least 2 weeks since prior therapy, if documented progressive disease (PD)
At least 4 weeks since prior therapy, if best response achieved without clear evidence of PD
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
No other malignancy within the past 5 years except:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active infection
HIV negative
No poorly controlled diabetes mellitus
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other: