Rituximab, Temozolomide, and Methylprednisolone in Treating Patients With Recurrent Primary CNS Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: rituximab; methylprednisolone; temozolomide
Intervention description: given IV days 1,8, 15 and 22; 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles); Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Rituximab; Temozolomide; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: primary central nervous system non-Hodgkin lymphoma

Summary:

      RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different
      ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and
      help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such
      as temozolomide and methylprednisolone, work in different ways to stop the growth of cancer
      cells, either by killing the cells or by stopping them from dividing. Rituximab may help
      chemotherapy kill more cancer cells by making cancer cells more sensitive to the drugs.
      Giving rituximab together with temozolomide and methylprednisolone may be an effective
      treatment for primary CNS non-Hodgkin's lymphoma.

      PURPOSE: This phase II trial is studying how well giving rituximab together with temozolomide
      and methylprednisolone works in treating patients with recurrent primary CNS non-Hodgkin's
      lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed primary CNS non-Hodgkin's lymphoma by brain biopsy, positive
             cerebrospinal fluid cytology, or vitrectomy

               -  Recurrent disease

          -  Measurable disease, define as bi-dimensionally measurable lesions with clearly defined
             margins by brain MRI or CT scan

               -  Radiographical evidence of tumor progression by MRI or CT scan

               -  Steroid therapy must be stable for 5 days prior to scan

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Karnofsky 60-100%

        Life expectancy

          -  More than 8 weeks

        Hematopoietic

          -  WBC ≥ 3,000/mm^3

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 10 g/dL (transfusion allowed)

        Hepatic

          -  SGOT < 2 times upper limit of normal (ULN)

          -  Bilirubin < 2 times ULN

          -  No active or latent hepatitis B infection

        Renal

          -  Creatinine < 1.5 mg/dL OR

          -  Creatinine clearance ≥ 60 mL/min

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No other malignancy within the past 3 years except nonmelanoma skin cancer or
             carcinoma in situ of the cervix

          -  No uncontrolled significant medical illness that would preclude study treatment

          -  No active infection

          -  No active HIV infection

          -  No concurrent disease that would dangerously alter drug metabolism or obscure toxicity

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  At least 7 days since prior interferon or thalidomide

          -  No concurrent prophylactic filgrastim (G-CSF)

          -  No concurrent immunotherapy

        Chemotherapy

          -  No prior temozolomide

          -  At least 14 days since prior methotrexate

          -  At least 21 days since prior procarbazine

          -  At least 42 days since prior nitrosoureas

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  See Disease Characteristics

          -  At least 7 days since prior tamoxifen

          -  No concurrent hormonal therapy

        Radiotherapy

          -  No concurrent radiotherapy

        Surgery

          -  Not specified

        Other

          -  Recovered from all prior therapy

          -  At least 28 days since prior investigational agents

          -  At least 28 days since other prior cytotoxic therapy

          -  At least 7 days since other prior non-cytotoxic agents (e.g., tretinoin)
             (radiosenitizers allowed)

          -  No other concurrent investigational drugs