Lymphoma Clinical Trial
Official title:
An Evaluation of Corticosteroid Pretreatment in Cutaneous T-Cell Lymphoma Patients Receiving Ontak (Denileukin Difitox)
RATIONALE: Denileukin diftitox may be able to deliver cancer-killing substances directly to
T-cell lymphoma cells. Dexamethasone may decrease the side effects of denileukin diftitox.
PURPOSE: Phase II trial to study the effectiveness of dexamethasone in preventing side
effects following treatment with denileukin diftitox in treating patients who have
persistent or recurrent T-cell lymphoma.
OBJECTIVES: I. Evaluate the potential benefit of dexamethasone administered prior to
denileukin diftitox in terms of avoidance and/or reduction of hypersensitivity type
reactions, flu-like symptom complex, and vascular leak syndrome side effects (adverse
events) in patients with persistent or recurrent cutaneous T-cell lymphoma. II. Assess the
response rate in terms of tumor burden reduction in these patients treated with this
regimen. III. Determine the rate of patient withdrawal from the study due to adverse
effects.
OUTLINE: This is an open label, multicenter study. Patients receive denileukin diftitox IV
over 30-60 minutes on days 1-5. Patients also receive oral dexamethasone twice daily
beginning 24 hours prior to and concomitantly with denileukin diftitox. Treatment continues
every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable
toxicity. Patients are followed at 2 or 4 weeks.
PROJECTED ACCRUAL: Approximately 15-30 patients will be accrued for this study.
;
Primary Purpose: Supportive Care
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