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

August 31, 2007
June 7, 2013
June 2006
June 2009   (final data collection date for primary outcome measure)
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.
Response rate [ Time Frame: 1 year ]
Complete list of historical versions of study NCT00523939 on ClinicalTrials.gov Archive Site
Time to Neurologic Progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
time to neurologic progression [ Time Frame: 2 years ]
Not Provided
Not Provided
 
DepoCyt for Active Lymphomatous or Leukemic Meningitis
Phase II Study of Intrathecal Therapy With 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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Neoplastic Meningitis
  • Lymphoma, B Cell
Drug: cytarabine liposome injection
50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses
Other Name: DepoCyt
  • Experimental: Lymphomatous
    Subjects with Lymphomatous Meningitis
    Intervention: Drug: cytarabine liposome injection
  • Experimental: Leukemic
    Subjects with Leukemic Meningitis
    Intervention: Drug: cytarabine liposome injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00523939
Pro00009742
No
Duke University
Duke University
Enzon Pharmaceuticals, Inc.
Principal Investigator: David Rizzieri, MD Duke University
Duke University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP