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DepoCyt for Active Lymphomatous or Leukemic Meningitis

Primary Purpose

Neoplastic Meningitis, Lymphoma, B Cell

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

cytarabine liposome injection

About this trial

This is an interventional treatment trial for Neoplastic Meningitis focused on measuring Lymphoma, Leukemia, Leukemic Meningitis, Lymphomatous Meningitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Lymphomatous

Leukemic

Arm Description

Subjects with Lymphomatous Meningitis

Subjects with Leukemic Meningitis

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to Neurologic Progression

Full Information

NCT ID

NCT00523939

First Posted

August 31, 2007

Last Updated

June 7, 2013

Sponsor

Duke University

Collaborators

Enzon Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00523939

Brief Title

DepoCyt for Active Lymphomatous or Leukemic Meningitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Terminated

Why Stopped

Low accrual.

Study Start Date

June 2006 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Enzon Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplastic Meningitis, Lymphoma, B Cell

Keywords

Lymphoma, Leukemia, Leukemic Meningitis, Lymphomatous Meningitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lymphomatous

Arm Type

Experimental

Arm Description

Subjects with Lymphomatous Meningitis

Arm Title

Leukemic

Arm Type

Experimental

Arm Description

Subjects with Leukemic Meningitis

Intervention Type

Drug

Intervention Name(s)

cytarabine liposome injection

Other Intervention Name(s)

DepoCyt

Intervention Description

50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses

Primary Outcome Measure Information:

Title

Response Rate

Description

To evaluate response rate using intrathecal DepoCytTM in two cohorts of patients, one with active lymphomatous meningitis and another with active leukemic meningitis.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Time to Neurologic Progression

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Rizzieri, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

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DepoCyt for Active Lymphomatous or Leukemic Meningitis

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