TriangleNCT01973062 · REGISTRY CONDITION SEARCH
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Primary Central Nervous System Non-Hodgkin Lymphoma
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- TERMINATED
- Registry last update
- 2020-07-24
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Radiographic Response Assessed by MRI or FDG-PET/MRI
Progression Free Survival
Overall Survival
Establish the Toxicity Profile of Ibritumomab Tiuxetan in This Patient Population.
Dosimetry Calculations of Yttrium Y 90 Ibritumomab Tiuxetan Assessed by PET/MRI
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Patients with histological diagnosis of recurrent or refractory primary central nervous system (CNS) lymphoma with at least 1 measurable gadolinium enhancing lesion on brain MRI scans * Karnofsky performance status (KPS) \>= 60 * Patients could not have had more than 3 prior therapy regimens for the treatment of PCNSL * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L * Platelets \>= 100 x 10\^9/L * Hemoglobin (Hgb) \> 10 g/dL * Serum total bilirubin =\< 1.5 x upper limit of normal (ULN) * Alanine aminotransferase (ALT) =\< 3.0 x ULN * Aspartate aminotransferase (AST) =\< 3.0 x ULN * Serum creatinine =\< 1.5 x ULN * Minimum interval since completion of radiation treatment is 12 weeks * Minimum interval since last drug therapy: * 3 weeks since the completion of non-cytotoxic agents * 4 weeks since the completion of a non-nitrosourea-containing regimen * 6 weeks since the completion of a nitrosourea-containing regimen * Patients must have signed an approved informed consent and authorization permitting release of personal health information * Patients are not on corticosteroids or on stable doses (less than 6 mg daily of dexamethasone) for more than 1 week before baseline imaging * Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception * Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission; patients with other prior malignancies must be disease-free for \>= three years Exclusion Criteria: * Pregnant or breast-feeding women * Patients unwilling or unable to comply with the protocol * Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active infection, uncontrolled diabetes, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness, etc.) that could cause unacceptable safety risks or compromise compliance with the protocol * Known diagnosis of human immunodeficiency virus (HIV) infection; prior radioimmunotherapy, prior myeloablative therapy with autologous bone marrow transplantation or peripheral stem cell rescue, and prior external beam radiation therapy to more than 25% of active bone marrow * Patients who have received filgrastim (G-CSF) or sargramostim (GM-CSF) within 2 weeks before treatment or major surgery within the prior 4 weeks
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Patients receive rituximab 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.
- intervention Names
- Biological: rituximab
- Radiation: yttrium Y 90 ibritumomab tiuxetan
- label
- rituximab and yttrium Y 90 ibritumomab tiuxetan
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- rituximab and yttrium Y 90 ibritumomab tiuxetan
- description
- Given IV
- name
- rituximab
- other Names
- IDEC-C2B8
- IDEC-C2B8 monoclonal antibody
- Mabthera
- MOAB IDEC-C2B8
- Rituxan
- type
- BIOLOGICAL
- arm Group Labels
- rituximab and yttrium Y 90 ibritumomab tiuxetan
- description
- Given IV
- name
- yttrium Y 90 ibritumomab tiuxetan
- other Names
- 90Y ibritumomab tiuxetan
- IDEC Y2B8
- Y90 Zevalin
- Y90-labeled ibritumomab tiuxetan
- type
- RADIATION
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 1
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Number of patients with at least a 50% reduction in tumor size on a MRI scan with stable or decreasing dose of corticosteroids
- measure
- Radiographic Response Assessed by MRI or FDG-PET/MRI
- time Frame
- Up to 2 years
- secondary Outcomes
- description
- The number of patients without an unequivocal increase in tumor size or the appearance of new lesions by MRI
- measure
- Progression Free Survival
- time Frame
- Up to 2 years
- description
- The number of patients alive up to two years after treatment
- measure
- Overall Survival
- time Frame
- Up to 2 years
- description
- Number of patients with toxicities related to the study drug
- measure
- Establish the Toxicity Profile of Ibritumomab Tiuxetan in This Patient Population.
- time Frame
- Up to 30 days following the last dose of study treatment
- description
- Number of Gy delivered to each tumor as calculated using the MIRD dosimetry formula on PET data
- measure
- Dosimetry Calculations of Yttrium Y 90 Ibritumomab Tiuxetan Assessed by PET/MRI
- time Frame
- At day 11
Full study description
- brief Summary
- 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.
- detailed Description
- 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.
Source references
Source notices and limitations
Discovery and provenance
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- query cond
- Primary Central Nervous System Lymphoma
- query disease state id
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- source file
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Preserved source evidence · Not medical advice