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DepoCyt for Active Lymphomatous or Leukemic Meningitis

This study has been terminated.
(Low accrual.)
Sponsor:
Collaborator:
Enzon Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00523939
First received: August 31, 2007
Last updated: June 7, 2013
Last verified: November 2012
  Purpose

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 Intervention Phase
Neoplastic Meningitis
Lymphoma, B Cell
Drug: cytarabine liposome injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Intrathecal Therapy With DepoCyt for Active Lymphomatous or Leukemic Meningitis

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Time to Neurologic Progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: June 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523939

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Enzon Pharmaceuticals, Inc.
Investigators
Principal Investigator: David Rizzieri, MD Duke University
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00523939     History of Changes
Other Study ID Numbers: Pro00009742
Study First Received: August 31, 2007
Results First Received: February 16, 2011
Last Updated: June 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Lymphoma
Leukemia
Leukemic Meningitis
Lymphomatous Meningitis

Additional relevant MeSH terms:
Meningitis
Lymphoma
Lymphoma, B-Cell
Meningeal Carcinomatosis
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Neoplasms
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Meningeal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014