A Randomized Pre-Phase II Trial of Interleukin-2, Interleukin-12, or No Additional Therapy Following Response to Ifosfamide/Etoposide Chemotherapy for Refractory HIV-Associated Non-Hodgkin's Lymphoma
I. Determine the efficacy of interleukin-12 (IL-12) by evaluating its effect on remission
duration after response to second line chemotherapy with ifosfamide and etoposide in
patients with HIV-associated non-Hodgkin's lymphoma.
II. Determine the safety of IL-12 when administered as maintenance therapy in these
III. Evaluate overall survival of this patient population. IV. Evaluate serum and tissue
cytokine levels in these patients. V. Evaluate the effect of IL-12 on HIV viral load and on
functional T-cell assays in these patients.
VI. Evaluate the effect of IL-12 on Epstein-Barr Virus (EBV) viral load in these patients.
OUTLINE: This is an open label study.
All patients receive ifosfamide IV by continuous infusion for 2 days, etoposide IV over 2
hours daily on days 1 and 2, and filgrastim (G-CSF) subcutaneously (SC) daily on days 4-13.
Courses are repeated every 21 days. Patients who have complete or partial remission after a
minimum of 4 courses of chemotherapy receive maintenance therapy consisting of
interleukin-12 SC twice weekly beginning on day 28 of the final chemotherapy course and
continuing for 6 months or until disease progression. All patients also receive combination
antiretroviral therapy during study.
Patients are followed every month for one year, then every 2 months thereafter.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Lawrence D. Kaplan, MD
University of California, San Francisco
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|USC/Norris Comprehensive Cancer Center||Los Angeles, California 90033-0800|
|Arthur G. James Cancer Hospital - Ohio State University||Columbus, Ohio 43210|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University||Chicago, Illinois 60611|
|Sylvester Cancer Center, University of Miami||Miami, Florida 33136|
|Mount Sinai School of Medicine||New York, New York 10029|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center||New York, New York 10016|
|San Francisco General Hospital Medical Center||San Francisco, California 94110|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|University Hospital/New Jersey Cancer Center||Newark, New Jersey 07103|