Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: rituximab
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: primary central nervous system non-Hodgkin lymphoma

Summary:

      RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill
      them or deliver cancer-killing substances to them without harming normal cells.

      PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have
      refractory or relapsed primary CNS lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed primary CNS lymphoma based on 1 of the following:

               -  Histologically confirmed non-Hodgkin's B-cell lymphoma by brain biopsy or
                  resection

               -  Positive cerebrospinal fluid (CSF) cytology or immunohistochemical diagnosis of
                  CSF monoclonality with or without measurable intracranial disease

               -  Histologically confirmed vitreal lymphoma with measurable intracranial tumor

          -  CD20 positive by brain biopsy

          -  Measurable (greater than 1 cm in diameter) tumor by CT scan or MRI

          -  Progressed during first-line chemotherapy and/or radiotherapy OR relapsed after
             initial successful treatment

          -  No systemic lymphoma by CT scan of the chest, abdomen, and pelvis with contrast

          -  No leptomeningeal lymphoma by lumbar puncture for CNS cytology/flow cytometry

          -  No ocular lymphoma by slit lamp examination

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Karnofsky 60-100%

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Hemoglobin at least 9.0 g/dL

        Hepatic

          -  Bilirubin less than 1.5 mg/dL

          -  Transaminases less than 4 times upper limit of normal

        Renal

          -  Creatinine less than 1.5 mg/dL

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 1 year after study
             participation

          -  HIV negative

          -  Mini mental status examination score at least 15

          -  No concurrent serious infection

          -  No other medical illness that would preclude study treatment

          -  No other malignancy within the past 5 years except curatively treated basal cell or
             squamous cell skin cancer or carcinoma in situ

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  More than 90 days since prior biologic therapy

          -  No prior rituximab

          -  No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF] or sargramostim
             [GM-CSF])

        Chemotherapy

          -  See Disease Characteristics

          -  At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  See Disease Characteristics

          -  At least 3 months since prior radiotherapy

        Surgery

          -  Not specified

        Other

          -  Recovered from prior therapy

          -  More than 90 days since prior investigational drugs

          -  More than 90 days since prior use of a therapeutic device