Primary Central Nervous System Non-Hodgkin Lymphoma Clinical Trial
Official title:
Phase II Study of Radioimmunotherapy With Zevalin (Ibritumomab Tiuxetan) Therapy for Patients With Refractory or Relapsed Primary Central Nervous System Lymphoma (PCNSL)
This phase II trial studies how well yttrium Y 90 ibritumomab tiuxetan and rituximab work in treating patients with recurrent or refractory primary central nervous system non-Hodgkin lymphoma. Radiolabeled monoclonal antibodies, such as yttrium 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells.
PRIMARY OBJECTIVES:
I. Determine the radiographic response proportion in patients with refractory or recurrent
primary central nervous system lymphoma (PCNSL) to ibritumomab tiuxetan (yttrium Y 90
ibritumomab tiuxetan) when given as an intravenous infusion.
SECONDARY OBJECTIVES:
I. Determine the progression free survival of patients treated with ibritumomab tiuxetan when
given as an intravenous infusion.
II. Determine the overall survival of patients treated with ibritumomab tiuxetan when given
as an intravenous infusion.
III. Establish the toxicity profile of ibritumomab tiuxetan in this patient population.
IV. Use positron emission tomography (PET)/magnetic resonance imaging (MRI) to map the
distribution of Y-90 ibritumomab tiuxetan, and calculate the Gy delivered based on the
activity found within tumor.
OUTLINE:
Patients receive rituximab intravenously (IV) on day 1. Within 7 to 9 days, patients receive
rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV in the absence of disease progression
or unacceptable toxicity. Distribution and dose absorbed dose will be assessed on day 11.
Quality of life will be assessed at screening, at day 1, 36, 92, and at each follow-up visit.
After completion of study treatment, patients are followed every 3-6 months for 2 years.
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