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Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation Clinical research trials and Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation. Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation clinical trial. Test subjects typically receive the most expert healthcare available for their Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation  Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation
Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation
For Condition: post-transplant lymphoproliferative disorder
Status: Not yet recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: 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 organtransplantation. 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.
Details: 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 of patients treated with this regimen. - Determine the response rate of patients treated with this regimen. - Determine the PTLD gene expression profile by microarray analysis and cytogenetics by karyotype and fluorescent in situ hybridization in these patients. - 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. Patients are followed at weeks 8 and 36 and then for at least 2 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /30 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed post-transplant lymphoproliferative disease (PTLD) - CD20 positive - Epstein-Barr virus positive - Must meet presentation criteria for 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 - Must have received prior solid organ transplantation - Must have residual disease after biopsy and/or surgery - No PTLD CNS disease, defined as positive cytology and/or radiographic evidence PATIENT CHARACTERISTICS: Age - Under 31 Performance status - NF-PTLD patients: - Karnofsky 50-100% (patients over age 16) - Lansky 50-100% (patients age 16 and under) 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasGross, Study Chair, Children's Hospital Columbus
Additional Information:
Study ID Numbers: CDR0000316241; COG-ANHL0221
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066469
Other Post-Transplant Lymphoproliferative Disorder Studies:
1. Reduced Immunosuppressive Therapy With or Without Donor White Blood Cells in Treating Patients With Lymphoproliferative Disease After Organ Transplantation
2. Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation
3. Autologous Cytotoxic T-Lymphocytes in Treating Patients With Relapsed Epstein-Barr Virus-Associated Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
4. Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder
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Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation
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