RATIONALE: Drugs used in chemotherapy such as cyclophosphamide, prednisone, and
methylprednisolone use different ways to stop cancer cells from dividing so they stop
growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either
kill them or deliver cancer-killing substances to them without harming normal cells.
Combining cyclophosphamide and either prednisone or methylprednisolone with rituximab may be
effective in treating lymphoproliferative disease following organ transplantation.
PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide and either
prednisone or methylprednisolone with rituximab in treating patients who have Epstein-Barr
virus-positive lymphoproliferative disease following organ transplantation.
- Determine the safety and toxicity of cyclophosphamide, rituximab, and prednisone or
methylprednisolone in patients with CD20-positive and Epstein-Barr virus-positive
post-transplant lymphoproliferative disease (PTLD) after solid organ transplantation.
- Determine the 2-year event-free survival, defined as alive and in continuous complete
remission with a functioning original allograft, of patients treated with this regimen.
- Determine the PTLD gene expression profile by microarray analysis and fluorescent in
OUTLINE: This is a multicenter study.
Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or
methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also
receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days
for up to 6 courses in the absence of disease progression, a new primary or secondary
malignancy, or unrelated disease.
After finishing study treatment, patients are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 60 patients (50 with non-fulminant post-transplant
lymphoproliferative disease [PTLD] and 10 fulminant PTLD) will be accrued for this study
within 2. 5-3 years.
Minimum age: N/A.
Maximum age: 30 Years.
Gender(s): Both.
Starship Children's Health, Auckland 1, New Zealand
Christchurch Hospital, Christchurch, New Zealand
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham, Birmingham, Alabama 35294, United States
University of Alberta Hospital, Edmonton, Alberta T6G 1Z2, Canada
Phoenix Children's Hospital, Phoenix, Arizona 85016-7710, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States
Children's & Women's Hospital of British Columbia, Vancouver, British Columbia V6H 3V4, Canada
Southern California Permanente Medical Group, Downey, California 90242-2814, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California 92354, United States
Kaiser Permanente Medical Center - Oakland, Sacramento, California 95825, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94115, United States
Stanford Cancer Center, Stanford, California 94305-5824, United States
Children's Hospital Center for Cancer and Blood Disorders, Aurora, Colorado 80045, United States
Alfred I. duPont Hospital for Children, Wilmington, Delaware 19803, United States
Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida 33901, United States
University of Florida Shands Cancer Center, Gainesville, Florida 32610-0232, United States
Nemours Children's Clinic, Jacksonville, Florida 32207, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida 33136, United States
Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida 32504, United States
All Children's Hospital, St. Petersburg, Florida 33701, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia 30322, United States
Children's Memorial Hospital - Chicago, Chicago, Illinois 60614, United States
University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States
University of Illinois Cancer Center, Chicago, Illinois 60612-7243, United States
Simmons Cooper Cancer Institute, Springfield, Illinois 62794-9677, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana 46202-5289, United States
Kosair Children's Hospital, Louisville, Kentucky 40232, United States
Tulane Cancer Center Office of Clinical Research, Alexandria, Louisiana 71315-3198, United States
CancerCare Manitoba, Winnipeg, Manitoba R3E 0V9, Canada
C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor, Michigan 48109-0286, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201-1379, United States
Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan 49503-2560, United States
CCOP - Kalamazoo, Kalamazoo, Michigan 49007-5341, United States
Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota 55455, United States
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
University of Mississippi Cancer Clinic, Jackson, Mississippi 39216-4505, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri 65203, United States
Children's Mercy Hospital, Kansas City, Missouri 64108, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, St. Louis, Missouri 63110, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska 68198-6805, United States
Sunrise Hospital and Medical Center, Las Vegas, Nevada 89109-2306, United States
Hackensack University Medical Center Cancer Center, Hackensack, New Jersey 07601, United States
Westmead Institute for Cancer Research at Westmead Hospital, Westmead, New South Wales 2145, Australia
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York 10032, United States
Mount Sinai Medical Center, New York, New York 10029, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York 14642, United States
SUNY Upstate Medical University Hospital, Syracuse, New York 13210, United States
New York Medical College, Valhalla, New York 10595, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27599-7295, United States
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina 28232-2861, United States
IWK Health Centre, Halifax, Nova Scotia B3K 6R8, Canada
Akron Children's Hospital, Akron, Ohio 44308-1062, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229-3039, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195, United States
Rainbow Babies and Children's Hospital, Cleveland, Ohio 44106-5000, United States
Nationwide Children's Hospital, Columbus, Ohio 43205-2696, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma 73104, United States
Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada
Legacy Emanuel Hospital and Health Center and Children's Hospital, Portland, Oregon 97227, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104-9786, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States
Hopital Sainte Justine, Montreal, Quebec H3T 1C5, Canada
Montreal Children's Hospital at McGill University Health Center, Montreal, Quebec H3H 1P3, Canada
Royal Children's Hospital, Brisbane, Queensland 4029, Australia
East Tennessee Children's Hospital, Knoxville, Tennessee 37901, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232-6838, United States
Driscoll Children's Hospital, Corpus Christi, Texas 78411, United States
Medical City Dallas Hospital, Dallas, Texas 75230, United States
Methodist Children's Hospital of South Texas, San Antonio, Texas 78229-3993, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas 78207, United States
Primary Children's Medical Center, Salt Lake City, Utah 84113-1100, United States
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont 05401, United States
Inova Fairfax Hospital, Falls Church, Virginia 22042-3300, United States
Children's Hospital of The King's Daughters, Norfolk, Virginia 23507-1971, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington 98105, United States
West Virginia University Health Sciences Center - Charleston, Charleston, West Virginia 25302, United States
Princess Margaret Hospital for Children, Perth, Western Australia 6001, Australia
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin 54449, United States