Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation
Lymphoproliferative Disorder
About this trial
This is an interventional treatment trial for Lymphoproliferative Disorder focused on measuring post-transplant lymphoproliferative disorder
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed post-transplant lymphoproliferative disease (PTLD) Presents with 1 of the following: Fulminant PTLD (F-PTLD) Fever greater than 38°C Hypotensive (for age) Evidence of multiple organ involvement/failure, including at least 2 of the following: Marrow (including pancytopenia without detectable B-cell proliferation) Liver (coagulopathy, transaminitis, and/or hyperbilirubinemia) Lungs (interstitial pneumonitis with or without pleural effusions) Gastrointestinal tract hemorrhage Non-fulminant PTLD (NF-PTLD) Does not meet the above F-PTLD criteria Considered medically refractory to reduced immune suppression (50% or more reduction of immunosuppression) for at least 1 week CD20 positive AND Epstein-Barr virus positive Must have received prior solid organ transplantation Must have residual disease after biopsy and/or surgery No PTLD central nervous system (CNS) disease, defined as positive cytology and/or radiographic evidence PATIENT CHARACTERISTICS: Age Under 31 Performance status Not specified Life expectancy NF-PTLD patients: At least 8 weeks Hematopoietic See Disease Characteristics Hepatic See Disease Characteristics Renal Not specified Pulmonary See Disease Characteristics Other Not pregnant or nursing Fertile patients must use effective contraception HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy More than 1 month since prior rituximab Chemotherapy More than 4 weeks since prior chemotherapy and recovered Endocrine therapy Not specified Radiotherapy Not specified Surgery See Disease Characteristics
Sites / Locations
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
- Phoenix Children's Hospital
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Southern California Permanente Medical Group
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
- Kaiser Permanente Medical Center - Oakland
- UCSF Helen Diller Family Comprehensive Cancer Center
- Stanford Cancer Center
- Children's Hospital Center for Cancer and Blood Disorders
- Alfred I. duPont Hospital for Children
- Lee Cancer Care of Lee Memorial Health System
- University of Florida Shands Cancer Center
- Nemours Children's Clinic
- University of Miami Sylvester Comprehensive Cancer Center - Miami
- Sacred Heart Cancer Center at Sacred Heart Hospital
- All Children's Hospital
- Winship Cancer Institute of Emory University
- University of Illinois Cancer Center
- Children's Memorial Hospital - Chicago
- University of Chicago Cancer Research Center
- Simmons Cooper Cancer Institute
- Indiana University Melvin and Bren Simon Cancer Center
- Kosair Children's Hospital
- Tulane Cancer Center Office of Clinical Research
- C.S. Mott Children's Hospital at University of Michigan Medical Center
- Barbara Ann Karmanos Cancer Institute
- Butterworth Hospital at Spectrum Health
- CCOP - Kalamazoo
- Masonic Cancer Center at University of Minnesota
- Mayo Clinic Cancer Center
- University of Mississippi Cancer Clinic
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- Children's Mercy Hospital
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- Sunrise Hospital and Medical Center
- Hackensack University Medical Center Cancer Center
- Mount Sinai Medical Center
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- SUNY Upstate Medical University Hospital
- New York Medical College
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Blumenthal Cancer Center at Carolinas Medical Center
- Akron Children's Hospital
- Cincinnati Children's Hospital Medical Center
- Rainbow Babies and Children's Hospital
- Cleveland Clinic Taussig Cancer Center
- Nationwide Children's Hospital
- Oklahoma University Cancer Institute
- Legacy Emanuel Hospital and Health Center and Children's Hospital
- Children's Hospital of Philadelphia
- Children's Hospital of Pittsburgh
- East Tennessee Children's Hospital
- Vanderbilt-Ingram Cancer Center
- Driscoll Children's Hospital
- Medical City Dallas Hospital
- University of Texas Health Science Center at San Antonio
- Methodist Children's Hospital of South Texas
- Primary Children's Medical Center
- Fletcher Allen Health Care - University Health Center Campus
- Inova Fairfax Hospital
- Children's Hospital of The King's Daughters
- Children's Hospital and Regional Medical Center - Seattle
- West Virginia University Health Sciences Center - Charleston
- Marshfield Clinic - Marshfield Center
- Westmead Institute for Cancer Research at Westmead Hospital
- Royal Children's Hospital
- Princess Margaret Hospital for Children
- University of Alberta Hospital
- Children's & Women's Hospital of British Columbia
- CancerCare Manitoba
- IWK Health Centre
- Hospital for Sick Children
- Montreal Children's Hospital at McGill University Health Center
- Hopital Sainte Justine
- Starship Children's Health
- Christchurch Hospital
Arms of the Study
Arm 1
Experimental
Cyclophosphamide, prednisone, rituximab
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