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DepoCyt for Active Lymphomatous or Leukemic Meningitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00523939
Recruitment Status : Terminated (Low accrual.)
First Posted : September 3, 2007
Results First Posted : March 14, 2011
Last Update Posted : June 17, 2013
Enzon Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Neoplastic Meningitis Lymphoma, B Cell Drug: cytarabine liposome injection Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Intrathecal Therapy With DepoCyt for Active Lymphomatous or Leukemic Meningitis
Study Start Date : June 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma Meningitis
Drug Information available for: Cytarabine

Arm Intervention/treatment
Experimental: Lymphomatous
Subjects with Lymphomatous Meningitis
Drug: cytarabine liposome injection
50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses
Other Name: DepoCyt

Experimental: Leukemic
Subjects with Leukemic Meningitis
Drug: cytarabine liposome injection
50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses
Other Name: DepoCyt

Primary Outcome Measures :
  1. Response Rate [ Time Frame: 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 :
  1. Time to Neurologic Progression [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00523939

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Enzon Pharmaceuticals, Inc.
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Principal Investigator: David Rizzieri, MD Duke University
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Responsible Party: Duke University Identifier: NCT00523939    
Other Study ID Numbers: Pro00009742
First Posted: September 3, 2007    Key Record Dates
Results First Posted: March 14, 2011
Last Update Posted: June 17, 2013
Last Verified: November 2012
Keywords provided by Duke University:
Leukemic Meningitis
Lymphomatous Meningitis
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Meningeal Carcinomatosis
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Central Nervous System Diseases
Nervous System Diseases
Lymphoma, Non-Hodgkin
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs