Finding studies
Finding studies
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Lead
City of Hope Medical Center
With
OBJECTIVES: * To evaluate the safety and efficacy of a new preparative regimen of yttrium Y 90 ibritumomab tiuxetan in combination with high-dose etoposide and cyclophosphamide followed by autologous stem cell transplantation (ASCT) for treatment of patients with poor-risk, relapsed, or refractory non-Hodgkin lymphoma (NHL). * To determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan which can be given with high-dose etoposide and high-dose cyclophosphamide followed by ASCT in patients with NHL. * To perform dosimetry study to estimate the radiation dose delivered to the tumor and normal organs. * To evaluate the short-term and long-term complications of this new preparative regimen. OUTLINE: This is a phase I does-escalation study of yttrium Y 90 ibritumomab tiuxetan followed by an open-label phase II study. * Preparation for transplantation: Peripheral blood stem cells (PBSCs) are collected via leukapheresis. Samples are analyzed by cytogenetic studies, immunophenotyping, and gene rearrangement. Patients with an adequate number of collected CD34-positive cells (≥ 3 times 10\^6 /kg) proceed to radioimmunotherapy. * Radioimmunotherapy: Patients receive yttrium Y 90 ibritumomab tiuxetan IV on days -21 and -14. Patients undergo bone marrow biopsy and dose estimation on day -7. * Chemotherapy: Patients receive etoposide IV on day -4 and cyclophosphamide IV over 2 hours on day -2. * Transplantation: Patients undergo reinfusion of PBSCs on day 1. * Growth factor therapy: Patients receive filgrastim (G-CSF) IV beginning on day 1 and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
