49
Participants
Start Date
March 14, 2004
Primary Completion Date
August 31, 2008
Study Completion Date
December 23, 2009
Denileukin diftitox
Denileukin diftitox will be administered intravenously (IV) at a dosage of 18 micrograms/kilogram/day (ug/kg/d) on Days 1 and 2 of each 21-Day cycle for a total of 6 cycles, with a maximum of 8 cycles.
Cyclophosphamide
Cyclophosphamide will be administered IV at a dosage of 750 milligrams/meter squared (mg/m\^2) on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.
Doxorubicin
Doxorubicin will be administered IV at a dosage of 50 mg/m\^2 on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.
Vincristine
Vincristine will be administered IV at a dosage of 1.4 mg/m\^2 on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.
Prednisone
Prednisone will be administered orally at a dosage of 100 mg on Days 3 to 7 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles.
Pegfilgrastim
Pegfilgrastim will be administered at a dosage of 6 mg subcutaneously on Day 4 to help prevent neutropenia. Alternatively, participants received filgrastim 5 ug/kg/d starting on Day 4 and continued until absolute neutrophil count (ANC) was less than 5000/millimeter squared (mm\^2) for 2 days post-nadir.
New York Oncology Hematology, P.C., Albany
Virginia Oncology Associates, Norfolk
Oncology and Hematology Associates of SW VA Inc., Salem
Raleigh Hematology Oncology Associates, Cary
Cancer Centers of the Carolinas, Greenville
Ocala Oncology Center, Ocala
Cancer Centers of Florida, P.A., Ocoee
Birmingham Hematology and Oncology, Birmingham
Barrett Cancer Center-University of Cincinnati, Cincinnati
Greater Dayton Cancer Center, Kettering
Siouxland Hematology Oncology, Sioux City
Minnesota Oncology Hematology, P.A., Minneapolis
Hematology Oncology Associates of IL, Chicago
Robert H. Lurie Comprehensive Cancer Center, Chicago
Rush University Medical Center, Chicago
Cancer Care & Hematology Specialists of Chicagoland, Niles
Arch Medical Services, St Louis
Kansas City Cancer Centers, Kansas City
St. Joseph Oncology Inc., Saint Joseph
Missouri Cancer Associates, Columbia
Kansas City Cancer Centers, Lenexa
The Texas Cancer Center, Dallas
Longview Cancer Center, Longview
Tyler Cancer Center, Tyler
Texas Cancer Center, Arlington
Texas Oncology,P.A., Bedford
Texas Oncology, Fort Worth
Waco Cancer Care and Research Center, Waco
HOAST Medical Dr., San Antonio
West Texas Cancer Center, Odessa
El Paso Cancer Treatment Center, El Paso
Rocky Mountain Cancer Center, Denver
Hematology Oncology Associates, Phoenix
New Mexico Cancer Care Associates, Santa Fe
Puget Sound Cancer Center, Edmonds
Northwest Cancer Specialists, Vancouver
Yakima Valley Memorial Hospital/North Star Lodge, Yakima
Cancer Care Northwest, Spokane
Stanford Cancer Center, Stanford
Yale University School of Medicine, New Haven
Dana Farber/ Harvard Cancer Center, Boston
New England Medical Center, Boston
Hackensack University Medical Center, Hackensack
Hematology Oncology Associates of NNJ, Morristown
Fox Chase Cancer Center, Philadelphia
Marnie McFaddin Ward Cancer Center, Beaumont
Texas Cancer Center at Medical City, Dallas
Texas Oncology, Garland
Allison Cancer Center, Midland
Eisai Inc.
INDUSTRY