Lymphoma Clinical Trial
Official title:
A Multicenter Phase II Evaluation Of ONTAK (DENILEUKINDIFTITOX) In Patients With Low Or Intermediate Grade-B-Cell Non-Hodgkin's Lymphoma Who Have Been Treated Previously With A Monoclonal Antibody Or Who Are Not Candidates For Monoclonal Antibody Therapy
RATIONALE: Biological therapies such as denileukin diftitox may be able to deliver
cancer-killing substances directly to non-Hodgkin's lymphoma cells.
PURPOSE: Phase II trial to study the effectiveness of denileukin diftitox in treating
patients who have non-Hodgkin's lymphoma.
OBJECTIVES: I. Determine the efficacy of denileukin diftitox in patients with stages I-IV
low- or intermediate-grade B-cell non-Hodgkin's lymphoma. II. Determine the safety of this
drug in these patients.
OUTLINE: This is a multicenter study. Patients receive denileukin diftitox IV over 30-60
minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity. Patients may receive up to 2 additional courses after achieving
complete response. Patients are followed every 3 months until they have progressed or for 2
years from date of termination.
PROJECTED ACCRUAL: A total of 58 patients (29 with low-grade non-Hodgkin's lymphoma (NHL)
and 29 with intermediate-grade NHL) will be accrued for this study within 12 months. The
study may be stopped after accrual of 20 patients (10 with low-grade NHL and 10 with
intermediate-grade NHL) if observed response rate is less than 1 in 10 for each stratum.
;
Primary Purpose: Treatment
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