DepoCyt for Active Lymphomatous or Leukemic Meningitis
Condition: Neoplastic Meningitis; Lymphoma, B Cell
MeSH terms: Lymphoma; Lymphoma, B-Cell; Meningeal Carcinomatosis; Meningitis
Intervention: cytarabine liposome injection
Intervention description: 50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses
Intervention MeSH terms: Cytarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lymphoma; Leukemia; Leukemic Meningitis; Lymphomatous Meningitis

Summary:

      The purpose of this study is to determine the response rate of lymphomatous meningitis or
      leukemic meningitis to DepoCyt. The safety of DepoCyt, the number of people who respond well
      to the study drug, and the response of symptoms to the study drug will also be determined.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cytologically confirmed, or radiographic evidence for lymphomatous or leukemic
             meningitis. If the CSF cytology is negative, patients must have MRI/CT brain and
             clinical findings consistent with neoplastic meningitis.

          -  Karnofsky Performance Score of 60 or above.

          -  Age ≥ 18 years.

          -  Patients must have adequate hematologic, renal and liver function. Laboratory

          -  Absolute neutrophil count (ANC) ≥ 1,500/mm3 or white blood cell count > 3,000/mm3

          -  Platelet count ≥ 100, 000/mm3

          -  BUN and serum creatinine must be ≤ 1.5 times upper limit of laboratory normal

          -  Total and direct serum bilirubin must be ≤ 1.5 times upper limit of laboratory normal

          -  SGOT and SGPT ≤ 3.0 times upper limit of laboratory normal

          -  Alkaline phosphatase derived from liver ≤ 2.0 times upper limit of laboratory normal

          -  No uncontrolled infection other than human immunodeficiency virus that is being
             treated with anti-retroviral therapy

          -  Patients who have had prior CNS radiation, prior intrathecal methotrexate, and prior
             CNS prophylaxis with intrathecal or intravenous cytarabine or methotrexate are
             eligible

          -  Written informed consent

        Exclusion Criteria:

          -  Experimental/Investigational chemotherapy, immunotherapy, or biologic therapy within
             four weeks prior to study

          -  Concurrent systemic chemotherapy with high dose methotrexate, high dose cytarabine, or
             high dose thiotepa (they cross the blood brain barrier at high levels)

          -  Patients receiving whole brain radiotherapy or craniospinal irradiation

          -  Previous (less than 2 years from diagnosis) or concurrent malignancies at other sites
             with the exception of fully treated carcinoma in situ of the cervix, basal cell
             carcinoma of the skin, and squamous cell carcinoma of the skin, or prostate cancer not
             requiring ongoing chemotherapy

          -  Pregnant or lactating women

          -  Known active meningeal infection

          -  Evidence of obstructive hydrocephalus requiring neurosurgical intervention