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Continuous Intraventricular Methotrexate in Treating Patients With Leptomeningeal Disease

Primary Purpose

Leptomeningeal Metastases

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pharmacological study
methotrexate
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leptomeningeal Metastases focused on measuring unspecified adult solid tumor, protocol specific

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects with leptomeningeal carcinomatosis (from solid tumors)
  • Subjects with lymphomatous or leukemic meningitis
  • The effects of methotrexate on the developing fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following the conclusion of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she will be excluded from the study and should inform her treating physical immediately
  • Karnofsky Performance Status greater than 70%
  • All subjects must have the ability to understand and the willingness to sign a written informed consent
  • We will exclude subjects who have had prior intrathecal/intraventricular therapy with methotrexate within 6 months

Exclusion Criteria:

  • Prior therapy with methotrexate for management of leptomeningeal disease
  • Subjects with evidence of hydrocephalous
  • Subjects with intraparenchymal lesions or bulky disease
  • Subjects with ventriculoperitoneal shunt in place
  • Previous history of whole brain radiation therapy
  • Subjects who, in the opinion of the principal investigator, may not be able to comply with the safety monitoring requirements of the study will not be included in this trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment (intraventricular chemotherapy)

    Arm Description

    Patients receive intraventricular methotrexate continuously on days 1-14. Treatment continues in the absence of disease progression or unacceptable toxicity.

    Outcomes

    Primary Outcome Measures

    Efficacy of continuously delivered intraventricular methotrexate
    The concentration of methotrexate in the brain parenchyma will be determined with microdialysis probe placed next to the ventricle.
    Pharmacokinetics of continuous intraventricular infusion of methotrexate
    Determined by measuring brain interstitial levels of methotrexate using microdialysis catheters, lumbar cerebral spinal fluid (CSF) levels (a distant site) of methotrexate via a lumbar drain during the inpatients phase, ventricular CSF levels of methotrexate using the Ommaya reservoir, and systemic levels of methotrexate in the blood.

    Secondary Outcome Measures

    Response rate of continuous intraventricular methotrexate infusion
    Toxicities of continuous intraventricular methotrexate infusion
    Pharmacodynamics of continuously delivered intraventricular methotrexate

    Full Information

    First Posted
    September 19, 2011
    Last Updated
    November 8, 2012
    Sponsor
    City of Hope Medical Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01438021
    Brief Title
    Continuous Intraventricular Methotrexate in Treating Patients With Leptomeningeal Disease
    Official Title
    Characterization of the Pharmacokinetics and Efficacy of Intraventricular Methotrexate Continuously Delivered Via a Mini Pump for Treatment of Leptomeningeal Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of funding
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    November 2013 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    City of Hope Medical Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This pilot clinical trial studies continuous intraventricular methotrexate in treating patients with leptomeningeal disease. Drugs used in chemotherapy, such as methotrexate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the ventricles may be an effective treatment for patients with leptomeningeal disease
    Detailed Description
    PRIMARY OBJECTIVES: I. Determine the pharmacokinetics and efficacy of continuous intraventricular methotrexate infusion in the treatment of leptomeningeal disease. SECONDARY OBJECTIVES: I. Describe the dose limiting toxicities. II. Describe the pharmacodynamics of continuously delivered intraventricular methotrexate. III. Assess for response. OUTLINE: Patients receive intraventricular methotrexate continuously on days 1-14. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leptomeningeal Metastases
    Keywords
    unspecified adult solid tumor, protocol specific

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment (intraventricular chemotherapy)
    Arm Type
    Experimental
    Arm Description
    Patients receive intraventricular methotrexate continuously on days 1-14. Treatment continues in the absence of disease progression or unacceptable toxicity.
    Intervention Type
    Other
    Intervention Name(s)
    pharmacological study
    Other Intervention Name(s)
    pharmacological studies
    Intervention Description
    Correlative studies
    Intervention Type
    Drug
    Intervention Name(s)
    methotrexate
    Other Intervention Name(s)
    amethopterin, Folex, methylaminopterin, Mexate, MTX
    Intervention Description
    Given intraventricularly
    Primary Outcome Measure Information:
    Title
    Efficacy of continuously delivered intraventricular methotrexate
    Description
    The concentration of methotrexate in the brain parenchyma will be determined with microdialysis probe placed next to the ventricle.
    Time Frame
    Day 3 after start of treatment
    Title
    Pharmacokinetics of continuous intraventricular infusion of methotrexate
    Description
    Determined by measuring brain interstitial levels of methotrexate using microdialysis catheters, lumbar cerebral spinal fluid (CSF) levels (a distant site) of methotrexate via a lumbar drain during the inpatients phase, ventricular CSF levels of methotrexate using the Ommaya reservoir, and systemic levels of methotrexate in the blood.
    Time Frame
    Day 14 after start of treatment
    Secondary Outcome Measure Information:
    Title
    Response rate of continuous intraventricular methotrexate infusion
    Time Frame
    Day 42 after start of treatment
    Title
    Toxicities of continuous intraventricular methotrexate infusion
    Time Frame
    Day 3 after start of treatment
    Title
    Pharmacodynamics of continuously delivered intraventricular methotrexate
    Time Frame
    Day 42 after start of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects with leptomeningeal carcinomatosis (from solid tumors) Subjects with lymphomatous or leukemic meningitis The effects of methotrexate on the developing fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following the conclusion of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she will be excluded from the study and should inform her treating physical immediately Karnofsky Performance Status greater than 70% All subjects must have the ability to understand and the willingness to sign a written informed consent We will exclude subjects who have had prior intrathecal/intraventricular therapy with methotrexate within 6 months Exclusion Criteria: Prior therapy with methotrexate for management of leptomeningeal disease Subjects with evidence of hydrocephalous Subjects with intraparenchymal lesions or bulky disease Subjects with ventriculoperitoneal shunt in place Previous history of whole brain radiation therapy Subjects who, in the opinion of the principal investigator, may not be able to comply with the safety monitoring requirements of the study will not be included in this trial
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mike Chen, MD
    Organizational Affiliation
    City of Hope Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Continuous Intraventricular Methotrexate in Treating Patients With Leptomeningeal Disease

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