Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation

PHASE2CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

April 30, 2004

Primary Completion Date

October 1, 2009

Study Completion Date

December 31, 2013

Conditions
Lymphoproliferative Disorder
Interventions
BIOLOGICAL

rituximab

Cycles 1 and 2 only: Given IV Incremental: First dosage: \< 21 years of age: 0.5mg/kg/hr (maximum of 50 mg/hr) for the 1st hour ≥ 21 years of age: 50 mg/hr for the 1st hour. Subsequent dosages: \< 21 years of age: 1.0mg/kg/hr (maximum of 50 mg/hr) for the 1st hour ≥ 21 years of age: 100 mg/hr for the 1st hour. Days 1, 8 and 15.

DRUG

cyclophosphamide

Given IV over 30-60 minutes Dose 600 mg/m2 in 50-250 mL of normal saline (NS) or Dextrose-Water 5%(D5W) (at a maximum concentration of 20 mg/ml) over 30-60 minutes on day 1 of each cycle

DRUG

methylprednisolone

Methylprednisolone 0.8 mg/kg IV over 12 hours on days 1,2,3,4 and 5 of each cycle.

DRUG

prednisone

Dosage 1 mg/kg orally every 12 hours on days 1,2,3,4 and 5 of each cycle. Oral prednisone may be rounded up to the nearest 2.5 mg as necessary for tablet size

Trial Locations (78)

1

Starship Children's Health, Auckland

2145

Westmead Institute for Cancer Research at Westmead Hospital, Westmead

4029

Royal Children's Hospital, Brisbane

6001

Princess Margaret Hospital for Children, Perth

10029

Mount Sinai Medical Center, New York

10032

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York

10595

New York Medical College, Valhalla

13210

SUNY Upstate Medical University Hospital, Syracuse

14642

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester

15213

Children's Hospital of Pittsburgh, Pittsburgh

19803

Alfred I. duPont Hospital for Children, Wilmington

25302

West Virginia University Health Sciences Center - Charleston, Charleston

30322

Winship Cancer Institute of Emory University, Atlanta

32207

Nemours Children's Clinic, Jacksonville

32504

Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola

33136

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami

33701

All Children's Hospital, St. Petersburg

33901

Lee Cancer Care of Lee Memorial Health System, Fort Myers

35294

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham, Birmingham

37901

East Tennessee Children's Hospital, Knoxville

40232

Kosair Children's Hospital, Louisville

44195

Cleveland Clinic Taussig Cancer Center, Cleveland

54449

Marshfield Clinic - Marshfield Center, Marshfield

55455

Masonic Cancer Center at University of Minnesota, Minneapolis

55905

Mayo Clinic Cancer Center, Rochester

60614

Children's Memorial Hospital - Chicago, Chicago

63110

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, St Louis

64108

Children's Mercy Hospital, Kansas City

65203

Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia

72205

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock

73104

Oklahoma University Cancer Institute, Oklahoma City

75230

Medical City Dallas Hospital, Dallas

78207

University of Texas Health Science Center at San Antonio, San Antonio

78411

Driscoll Children's Hospital, Corpus Christi

80045

Children's Hospital Center for Cancer and Blood Disorders, Aurora

92354

Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda

94115

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco

95825

Kaiser Permanente Medical Center - Oakland, Sacramento

97227

Legacy Emanuel Hospital and Health Center and Children's Hospital, Portland

98105

Children's Hospital and Regional Medical Center - Seattle, Seattle

85016-7710

Phoenix Children's Hospital, Phoenix

90242-2814

Southern California Permanente Medical Group, Downey

94305-5824

Stanford Cancer Center, Stanford

32610-0232

University of Florida Shands Cancer Center, Gainesville

60612-7243

University of Illinois Cancer Center, Chicago

60637-1470

University of Chicago Cancer Research Center, Chicago

62794-9677

Simmons Cooper Cancer Institute, Springfield

46202-5289

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

71315-3198

Tulane Cancer Center Office of Clinical Research, Alexandria

48109-0286

C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor

48201-1379

Barbara Ann Karmanos Cancer Institute, Detroit

49503-2560

Butterworth Hospital at Spectrum Health, Grand Rapids

49007-5341

CCOP - Kalamazoo, Kalamazoo

39216-4505

University of Mississippi Cancer Clinic, Jackson

68198-6805

UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha

89109-2306

Sunrise Hospital and Medical Center, Las Vegas

07601

Hackensack University Medical Center Cancer Center, Hackensack

27599-7295

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill

28232-2861

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte

44308-1062

Akron Children's Hospital, Akron

45229-3039

Cincinnati Children's Hospital Medical Center, Cincinnati

44106-5000

Rainbow Babies and Children's Hospital, Cleveland

43205-2696

Nationwide Children's Hospital, Columbus

19104-9786

Children's Hospital of Philadelphia, Philadelphia

37232-6838

Vanderbilt-Ingram Cancer Center, Nashville

78229-3993

Methodist Children's Hospital of South Texas, San Antonio

84113-1100

Primary Children's Medical Center, Salt Lake City

05401

Fletcher Allen Health Care - University Health Center Campus, Burlington

22042-3300

Inova Fairfax Hospital, Falls Church

23507-1971

Children's Hospital of The King's Daughters, Norfolk

T6G 1Z2

University of Alberta Hospital, Edmonton

V6H 3V4

Children's & Women's Hospital of British Columbia, Vancouver

R3E 0V9

CancerCare Manitoba, Winnipeg

B3K 6R8

IWK Health Centre, Halifax

M5G 1X8

Hospital for Sick Children, Toronto

H3H 1P3

Montreal Children's Hospital at McGill University Health Center, Montreal

H3T 1C5

Hopital Sainte Justine, Montreal

Unknown

Christchurch Hospital, Christchurch

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Children's Oncology Group

NETWORK

NCT00066469 - Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation | Biotech Hunter | Biotech Hunter