DepoCyt for Active Lymphomatous or Leukemic Meningitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study of Intrathecal Therapy With DepoCyt for Active Lymphomatous or Leukemic Meningitis

Conditions
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Neoplastic Meningitis, Lymphoma, B Cell

Intervention / Treatment
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* Drug: cytarabine liposome injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lymphomatous<br>Subjects with Lymphomatous Meningitis | Drug: cytarabine liposome injection<br>* 50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses<br>* Other names: DepoCyt;|
| Experimental: Leukemic<br>Subjects with Leukemic Meningitis | Drug: cytarabine liposome injection<br>* 50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses<br>* Other names: DepoCyt;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | To evaluate response rate using intrathecal DepoCytTM in two cohorts of patients, one with active lymphomatous meningitis and another with active leukemic meningitis. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Neurologic Progression |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoma, Leukemia, Leukemic Meningitis, Lymphomatous Meningitis