Trial record 4 of 293 for:
meningitis
DepoCyt for Active Lymphomatous or Leukemic Meningitis
This study has been terminated.
(Low accrual.)
Sponsor:
Duke University
Collaborator:
Enzon Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00523939
First received: August 31, 2007
Last updated: November 5, 2012
Last verified: November 2012
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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
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: | Pro00009010 |
| Study First Received: | August 31, 2007 |
| Results First Received: | February 16, 2011 |
| Last Updated: | November 5, 2012 |
| 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 Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Lymphoma, Non-Hodgkin Meningeal Neoplasms |
Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Cytarabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013