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
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.
Interventional
Primary Purpose: Treatment
Timothy M. Kuzel, MD
Study Chair
Robert H. Lurie Cancer Center
United States: Food and Drug Administration
CDR0000066692
NCT00003615
March 1999
Name | Location |
---|---|
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
Trinitas Hospital - Jersey Street Campus | Elizabeth, New Jersey 07201 |
Hunterdon Regional Cancer Center | Flemington, New Jersey 08822 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Overlook Hospital | Summit, New Jersey 07902-0220 |
Riverview Medical Center - Booker Cancer Center | Red Bank, New Jersey 07701 |