Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Primary Central Nervous System Non-Hodgkin Lymphoma
Condition: Primary Central Nervous System Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: rituximab; yttrium Y 90 ibritumomab tiuxetan
Intervention description: Given IV; Given IV
Intervention MeSH terms: Rituximab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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