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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00691522
Recruitment Status : Terminated
First Posted : June 5, 2008
Last Update Posted : January 9, 2009
Sponsor:
Collaborator:
Celtic Pharma Development Services
Information provided by:
PharmaNet

Study Description
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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

Condition or disease Intervention/treatment Phase
Peritumoral Brain Edema PRIMARY MALIGNANT and METASTATIC BRAIN TUMORS Drug: Xerecept Phase 2

Expanded Access : PharmaNet has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2008
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors Edema

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Pharmanet
ClinicalTrials.gov Identifier: NCT00691522    
Other Study ID Numbers: CPDS 0701
First Posted: June 5, 2008    Key Record Dates
Last Update Posted: January 9, 2009
Last Verified: January 2009
Keywords provided by PharmaNet:
PERITUMORAL BRAIN EDEMA
PRIMARY MALIGNANT BRAIN TUMORS
METASTATIC BRAIN TUMORS
Additional relevant MeSH terms:
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Brain Neoplasms
Brain Edema
Edema
Central Nervous System Neoplasms
Nervous System Neoplasms
 Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases