Spots Global Cancer Trial Database for Denileukin Diftitox in Treating Patients With Non-Hodgkin's Lymphoma
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Trial Identification
Brief Title: Denileukin Diftitox in Treating Patients With Non-Hodgkin's Lymphoma
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 ID: NCT00026429
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
ION/Pharmatech Network, Pomona, California, United States
Cancer and Blood Institute of the Desert, Rancho Mirage, California, United States
Missouri Cancer Care, P.C., St. Charles, Missouri, United States
Nassau Hematology/Oncology PC, Lake Success, New York, United States
Coastal Cancer Center, Myrtle Beach, South Carolina, United States
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group, Memphis, Tennessee, United States
Contact Details
Name: Debby Henkens
Affiliation: Pharmatech Oncology
Role: STUDY_CHAIR
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