Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation
- Conditions
- Lymphoproliferative Disorder
- Interventions
- Registration Number
- NCT00066469
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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 response rate in patients treated with this regimen.
* Determine the PTLD gene expression profile by microarray analysis and fluorescent in situ hybridization in patients treated with this regimen.
* Determine the accrual rate of patients to this study.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cyclophosphamide, prednisone, rituximab 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 Cyclophosphamide, prednisone, rituximab methylprednisolone 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 Cyclophosphamide, prednisone, rituximab cyclophosphamide 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 Cyclophosphamide, prednisone, rituximab prednisone 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
- Primary Outcome Measures
Name Time Method Event-free Survival 2 years Alive in continuous complete remission with functioning original allograft. The Event Free Survival (EFS) will be estimated by the Kaplan-Meier method.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (78)
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
University of Illinois Cancer Center
🇺🇸Chicago, Illinois, United States
Children's Memorial Hospital - Chicago
🇺🇸Chicago, Illinois, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
Stanford Cancer Center
🇺🇸Stanford, California, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Simmons Cooper Cancer Institute
🇺🇸Springfield, Illinois, United States
Tulane Cancer Center Office of Clinical Research
🇺🇸Alexandria, Louisiana, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Akron Children's Hospital
🇺🇸Akron, Ohio, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Driscoll Children's Hospital
🇺🇸Corpus Christi, Texas, United States
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Westmead Institute for Cancer Research at Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
🇺🇸Miami, Florida, United States
Sacred Heart Cancer Center at Sacred Heart Hospital
🇺🇸Pensacola, Florida, United States
Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Lee Cancer Care of Lee Memorial Health System
🇺🇸Fort Myers, Florida, United States
All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Butterworth Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
University of Mississippi Cancer Clinic
🇺🇸Jackson, Mississippi, United States
Hackensack University Medical Center Cancer Center
🇺🇸Hackensack, New Jersey, United States
East Tennessee Children's Hospital
🇺🇸Knoxville, Tennessee, United States
Fletcher Allen Health Care - University Health Center Campus
🇺🇸Burlington, Vermont, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
West Virginia University Health Sciences Center - Charleston
🇺🇸Charleston, West Virginia, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Royal Children's Hospital
🇦🇺Brisbane, Queensland, Australia
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Children's & Women's Hospital of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Montreal Children's Hospital at McGill University Health Center
🇨🇦Montreal, Quebec, Canada
Starship Children's Health
🇳🇿Auckland, New Zealand
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Sunrise Hospital and Medical Center
🇺🇸Las Vegas, Nevada, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
🇺🇸Saint Louis, Missouri, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
🇺🇸New York, New York, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Children's Hospital of The King's Daughters
🇺🇸Norfolk, Virginia, United States
Masonic Cancer Center at University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Methodist Children's Hospital of South Texas
🇺🇸San Antonio, Texas, United States
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
New York Medical College
🇺🇸Valhalla, New York, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Oklahoma University Cancer Institute
🇺🇸Oklahoma City, Oklahoma, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital
🇺🇸Portland, Oregon, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Kaiser Permanente Medical Center - Oakland
🇺🇸Sacramento, California, United States
Children's Hospital Center for Cancer and Blood Disorders
🇺🇸Aurora, Colorado, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States