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Imaging Study of XERECEPT® Treatment for Peritumoral Brain Edema (PBE)

Primary Purpose

Peritumoral Brain Edema, PRIMARY MALIGNANT and METASTATIC BRAIN TUMORS

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Xerecept
Sponsored by
PharmaNet
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritumoral Brain Edema focused on measuring PERITUMORAL BRAIN EDEMA, PRIMARY MALIGNANT BRAIN TUMORS, METASTATIC BRAIN TUMORS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older.
  • Written informed consent has been provided and documented.
  • Primary malignant or metastatic brain tumor that is either asymptomatic or symptomatic patients with the life expectancy estimation of 3 months or more
  • A pretreatment MRI brain scan must identify at least 1 dominant tumor lesion and related PBE that is radiologically (or visibly) distinct from the main tumor mass; the combined tumor-edema lesion must be > 2 cm in longest diameter (for at least 1 slice) and visible in 3 consecutive, 4 mm sections on MRI.
  • No dexamethasone or anti-angiogenic treatment for at least 14 days prior to the Baseline and throughout the study.
  • A Karnofsky Performance Score > 60 at Screening (Visit 1) and at Baseline
  • A negative serum pregnancy test at the Screening (Visit 1) is required for women of childbearing potential.

Exclusion Criteria:

  • • Low-grade gliomas, recurrent gliomas, suspected lymphoma, or known human immunosuppressive virus (HIV) infection.

    • Patients requiring surgery, radiosurgery or radiation surgery therapy
    • Patients experiencing severe symptoms related to PBE
    • Patients where MRI is contraindicated for any reason.
    • Signs and/or symptoms of relatively severe cerebral herniation.
    • Concurrent enrollment in any other investigational drug or device study, or plan to enroll in such a study during the 3 to 4 weeks of study treatment.
    • Systemic corticosteroid use (with the exception of inhalers for asthma).
    • Use of dexamethasone (eg, as an anti-emetic) during screening or during the study
    • Use of anti-angiogenic/anti-vascular endothelial growth factor (VEGF) therapy or anticonvulsant therapy (if patient's liver function tests (LFTs) are > 3 times upper limit of normal) 14 days prior to randomization
    • Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal, or endocrine metabolic disease, which in the opinion of the Investigator or the Medical Monitor, would put the patient as unusual risk during study participation.
    • Known renal insufficiency or screening glomerular filtration rate (GFR) < 60 mL/min/1.73 m2.
    • Central nervous system infection, human immunosuppressive virus (HIV) positive or ongoing infectious process.
    • For female patients: pregnancy, breastfeeding or refusal to practice birth control if of childbearing potential during the study.
    • Inability of the patient to follow the treatment regimen.
    • Known history of methionine allergy.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 2, 2008
    Last Updated
    January 8, 2009
    Sponsor
    PharmaNet
    Collaborators
    Celtic Pharma Development Services
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00691522
    Brief Title
    Imaging Study of XERECEPT® Treatment for Peritumoral Brain Edema (PBE)
    Official Title
    Open-Label, Imaging Study of Human Corticotropin-Releasing Factor (hCRF) for The Reduction of Peritumoral Brain Edema (PBE) in Patients With Primary Malignant or Metastatic Brain Tumors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Terminated
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    August 2009 (Anticipated)
    Study Completion Date
    October 2009 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    PharmaNet
    Collaborators
    Celtic Pharma Development Services

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a phase II, multicenter, open-label, imaging study of hCRF in the reduction of PBE in patients with primary malignant or metastatic brain tumors. Approximately 30 to 60 patients will be assigned to 1 of 3 treatment groups and receive study drug for up to 28 days
    Detailed Description
    The purpose of this study is to investigate the effect of 3 different regimens of subcutaneous (SC) administered hCRF (1.0 mg every [Q] 8 hours [h], 1.5 mg Q12h, and 1.0 mg Q12h) on the reduction of PBE in patients with primary malignant or metastatic brain tumors as defined by MRI indexes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peritumoral Brain Edema, PRIMARY MALIGNANT and METASTATIC BRAIN TUMORS
    Keywords
    PERITUMORAL BRAIN EDEMA, PRIMARY MALIGNANT BRAIN TUMORS, METASTATIC BRAIN TUMORS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Xerecept

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older. Written informed consent has been provided and documented. Primary malignant or metastatic brain tumor that is either asymptomatic or symptomatic patients with the life expectancy estimation of 3 months or more A pretreatment MRI brain scan must identify at least 1 dominant tumor lesion and related PBE that is radiologically (or visibly) distinct from the main tumor mass; the combined tumor-edema lesion must be > 2 cm in longest diameter (for at least 1 slice) and visible in 3 consecutive, 4 mm sections on MRI. No dexamethasone or anti-angiogenic treatment for at least 14 days prior to the Baseline and throughout the study. A Karnofsky Performance Score > 60 at Screening (Visit 1) and at Baseline A negative serum pregnancy test at the Screening (Visit 1) is required for women of childbearing potential. Exclusion Criteria: • Low-grade gliomas, recurrent gliomas, suspected lymphoma, or known human immunosuppressive virus (HIV) infection. Patients requiring surgery, radiosurgery or radiation surgery therapy Patients experiencing severe symptoms related to PBE Patients where MRI is contraindicated for any reason. Signs and/or symptoms of relatively severe cerebral herniation. Concurrent enrollment in any other investigational drug or device study, or plan to enroll in such a study during the 3 to 4 weeks of study treatment. Systemic corticosteroid use (with the exception of inhalers for asthma). Use of dexamethasone (eg, as an anti-emetic) during screening or during the study Use of anti-angiogenic/anti-vascular endothelial growth factor (VEGF) therapy or anticonvulsant therapy (if patient's liver function tests (LFTs) are > 3 times upper limit of normal) 14 days prior to randomization Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal, or endocrine metabolic disease, which in the opinion of the Investigator or the Medical Monitor, would put the patient as unusual risk during study participation. Known renal insufficiency or screening glomerular filtration rate (GFR) < 60 mL/min/1.73 m2. Central nervous system infection, human immunosuppressive virus (HIV) positive or ongoing infectious process. For female patients: pregnancy, breastfeeding or refusal to practice birth control if of childbearing potential during the study. Inability of the patient to follow the treatment regimen. Known history of methionine allergy.

    12. IPD Sharing Statement

    Learn more about this trial

    Imaging Study of XERECEPT® Treatment for Peritumoral Brain Edema (PBE)

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