Denileukin Diftitox in Treating Patients With Non-Hodgkin's Lymphoma
RATIONALE: Immunotoxins such as denileukin diftitox can locate cancer cells and kill them without harming normal cells. This may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: Phase II trial to study the effectiveness of denileukin diftitox in treating patients who have non-Hodgkin's lymphoma that has not responded to previous treatment.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of DAB 389 IL-2, an Interleukin-2 Fusion Toxin, for Previously Treated Stage II, III, and IV Follicular Low-Grade Non-Hodgkin's Lymphoma|
|Study Start Date:||March 1999|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the objective response rate in patients with previously treated stage I, II, III, or IV low- or intermediate-grade B-cell non-Hodgkin's lymphoma treated with denileukin diftitox. II. Determine the time to progression, duration of remission, and time to treatment failure in patients after treatment with this therapy. III. Determine the toxicity of this therapy in these patients. IV. Correlate the results of the inteleukin-2 receptor assay with treatment outcomes in these patients.
OUTLINE: Patients are stratified according to interleukin-2 receptor classification (positive vs negative). Patients receive immunotoxin therapy with denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment repeats every 21 days for 2-6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for the interleukin-2 (IL-2) receptor-positive stratum and a total of 11-44 patients will be accrued for the IL-2 receptor-negative stratum.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003615
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Nevada|
|CCOP - Southern Nevada Cancer Research Foundation|
|Las Vegas, Nevada, United States, 89106|
|United States, New Jersey|
|Trinitas Hospital - Jersey Street Campus|
|Elizabeth, New Jersey, United States, 07201|
|Hunterdon Regional Cancer Center|
|Flemington, New Jersey, United States, 08822|
|Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|Morristown Memorial Hospital|
|Morristown, New Jersey, United States, 07962-1956|
|Riverview Medical Center - Booker Cancer Center|
|Red Bank, New Jersey, United States, 07701|
|Summit, New Jersey, United States, 07902-0220|
|United States, Pennsylvania|
|CCOP - Geisinger Clinic and Medical Center|
|Danville, Pennsylvania, United States, 17822-2001|
|Study Chair:||Timothy M. Kuzel, MD||Robert H. Lurie Cancer Center|