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About
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving rituximab and chemotherapy together with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of yttrium Y 90 ibritumomab tiuxetan when given together with rituximab, fludarabine, and cyclophosphamide and to see how well they work in treating patients with relapsed B-cell non-Hodgkin's lymphoma.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a prospective, nonrandomized, multicenter, phase I dose-escalation study of yttrium Y 90 (^90Y) ibritumomab tiuxetan followed by a phase II open-label study.
Phase I:
Cohorts of 3-6 patients receive escalating doses of ^90Y ibritumomab tiuxetan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 2 years.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed CD20-positive B-cell non-Hodgkin's lymphoma (NHL), including any of the following subtypes:
Indolent NHL, including any of the following:
Mantle cell NHL
Transformed B-cell NHL
In at least first relapse with an indication for systemic antineoplastic treatment, as defined by the following:
Measurable lesions of lymphoma infiltration
Medically ineligible for high-dose treatment followed by autologous stem cell support
Adequate bone marrow cellularity (> 15% of marrow area covered by hematopoiesis)
No CNS, leptomeningeal, spinal cord, or testes lymphoma involvement
No lymphoma lesion mandating emergency radiotherapy
No clinical, cytological, cytogenetic, or histopathologic indication of myelodysplastic syndrome
If there is bone marrow infiltration detected prior to chemoimmunotherapy, patient must undergo a repeat bone marrow biopsy prior to planned treatment with radioimmunotherapy to verify the level of bone marrow infiltration is < 25%
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Life expectancy ≥ 3 months
Absolute neutrophil count > 1,500/mm³
Platelet count > 150,000/mm³
Hemoglobin > 9 g/dL
Creatinine < 1.5 times upper limit of normal (ULN)
Bilirubin < 2 times ULN
ALT and AST < 2 times ULN
Albumin > 2.5 g/dL
INR < 1.5
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for ≥ 12 months after completion of study treatment
No concurrent severe and/or uncontrolled medical disease that would preclude study compliance, including any of the following:
No bleeding risks or disorders, including any of the following:
No ongoing autoimmune hemolytic anemia
No known presence of anti-murine antibody reactivity
No known hypersensitivity to murine or chimeric antibodies or proteins
No known HIV infection
No psychiatric illness that would preclude study requirements
No other malignant disorder within the past 10 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
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Data sourced from clinicaltrials.gov
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