DepoCyt for Active Lymphomatous or Leukemic Meningitis

Phase 2

Terminated

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Lymphomatous	cytarabine liposome injection	Subjects with Lymphomatous Meningitis
Leukemic	cytarabine liposome injection	Subjects with Leukemic Meningitis

Primary Outcome Measures

Name	Time	Method
Response Rate	1 year	To evaluate response rate using intrathecal DepoCytTM in two cohorts of patients, one with active lymphomatous meningitis and another with active leukemic meningitis.

Secondary Outcome Measures