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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Given IV
Given IV
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Radiographic Response Assessed by MRI or FDG-PET/MRI
Number of patients with at least a 50% reduction in tumor size on a MRI scan with stable or decreasing dose of corticosteroids
Time frame: Up to 2 years
Progression Free Survival
The number of patients without an unequivocal increase in tumor size or the appearance of new lesions by MRI
Time frame: Up to 2 years
Overall Survival
The number of patients alive up to two years after treatment
Time frame: Up to 2 years
Establish the Toxicity Profile of Ibritumomab Tiuxetan in This Patient Population.
Number of patients with toxicities related to the study drug
Time frame: Up to 30 days following the last dose of study treatment
Dosimetry Calculations of Yttrium Y 90 Ibritumomab Tiuxetan Assessed by PET/MRI
Number of Gy delivered to each tumor as calculated using the MIRD dosimetry formula on PET data
Time frame: At day 11
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