DepoCyt for Active Lymphomatous or Leukemic Meningitis
DepoCyt for Active Lymphomatous or Leukemic Meningitis
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.
DepoCyt is a sustained-release formulation of the chemotherapy drug, cytarabine (Ara-C),
 which is used for the treatment of patients with lymphomatous or leukemic meningitis, a
 complication of lymphoma/leukemia that is characterized by the spread of cancer to the
 central nervous system.

 DepoCyt is introduced into the spinal fluid, through a needle inserted into the spinal canal
 or through a reservoir placed under the scalp by a neurosurgeon. DepoCyt will be given every
 two weeks i.e. week 1 and week 3 initially. After the second dose, a lumbar puncture will be
 done to check the spinal fluid for cancer cells. If there has been a good response, DepoCyt
 will be given every 14 days for 6 doses i.e., weeks 5, 7, 9, 11, 13, 15 and then every 28
 days for six doses i.e., weeks 19, 23, 27, 31, 35, and 39. Blood tests and lumbar punctures
 will be done throughout the study.
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