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Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation
Not Recruiting
Trial ID: NCT00066469
Purpose
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.
Official Title
Phase II Study of Cyclophosphamide, Prednisone and Rituximab (CPR) in Children, Adolescents and Young Adults With B-lymphocyte Antigen CD20 (CD20) Positive Post-Transplant Lymphoproliferative Disease (PTLD) Following Solid Organ Transplantation (SOT)
Stanford Investigator(s)
Eligibility
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
Intervention(s):
biological: rituximab
drug: cyclophosphamide
drug: methylprednisolone
drug: prednisone
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Min Wang
6507364281