Monoclonal Antibody Therapy in Treating Patients With Lymphoproliferative Disorder Associated Wit… (NCT00003716) | Clinical Trial Compass
CompletedPhase 2
Monoclonal Antibody Therapy in Treating Patients With Lymphoproliferative Disorder Associated With Immunosuppression Therapy
United States25 participantsStarted 1998-03
Plain-language summary
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have lymphoproliferative disorder that is associated with immunosuppression therapy.
Who can participate
Age range3 Years – 70 Years
SexALL
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DISEASE CHARACTERISTICS: Polyclonal or monoclonal B-cell lymphoproliferative disorder while under pharmacologic immune suppression for control of either allograft rejection or autoimmune disease Measurable disease as defined by one of the following: At least 1 tumor mass measuring 1.0 cm in largest dimension Greater than 25% marrow involvement Quantifiable extranodal disease Expression of CD20 antigen confirmed by biopsy or fine needle aspirate Progression of disease or stable disease following reduction of immunosuppressive medication and antiviral therapy Inability to further reduce immunosuppressive medication
PATIENT CHARACTERISTICS: Age: 3 to 70 Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 50,000/mm3 Hepatic: Not specified Renal: Not specified Cardiovascular: No congestive heart failure Pulmonary: No pneumonitis Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No serious nonmalignant disease No active uncontrolled bacterial, viral, or fungal infections
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) No concurrent chemotherapy Endocrine therapy: At least 2 weeks since change in dosing and type of immunosuppressive drugs unless due to progression of disease Radiotherapy: At least 4 w…