Denileukin Diftitox in Treating Patients With Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00026429|
Recruitment Status : Unknown
Verified February 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : February 27, 2004
Last Update Posted : December 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma||Biological: denileukin diftitox||Phase 2|
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.
|Study Type :||Interventional (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|
|Study Start Date :||January 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|