Denileukin Diftitox in Treating Patients With Non-Hodgkin's Lymphoma
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.
|Study Design:||Primary Purpose: Treatment|
|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|
|Study Start Date:||January 2001|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00026429
|United States, California|
|Pomona, California, United States, 91767|
|Cancer and Blood Institute of the Desert|
|Rancho Mirage, California, United States, 92270|
|United States, Missouri|
|Missouri Cancer Care, P.C.|
|St. Charles, Missouri, United States, 63301|
|United States, New York|
|Nassau Hematology/Oncology PC|
|Lake Success, New York, United States, 11042|
|United States, South Carolina|
|Coastal Cancer Center|
|Myrtle Beach, South Carolina, United States, 29572|
|United States, Tennessee|
|Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group|
|Memphis, Tennessee, United States, 38119|
|Study Chair:||Debby Henkens||Pharmatech Oncology|