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

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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

Tracking Information
First Submitted Date  ICMJE June 2, 2008
First Posted Date  ICMJE June 5, 2008
Last Update Posted Date January 9, 2009
Study Start Date  ICMJE November 2008
Estimated Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2008)
To investigate the effect of 3 different regimens SC of hCRF on the reduction of PBE in patients with primary malignant or metastatic brain tumors as defined by MRI indexes. [ Time Frame: MRI-derived measurements of the differences in mean diffusivity ]
Change History Complete list of historical versions of study NCT00691522 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2008)
To evaluate the safety of hCRF in the treatment of PBE patients with primary malignant or metastatic brain tumors To establish the percentage of responders as measured by clinical and radiographic means To identify tumor and PBE changes [ Time Frame: General laboratory, physical and neurological examinations, AEs/SAEs ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imaging Study of XERECEPT® Treatment for Peritumoral Brain Edema (PBE)
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Peritumoral Brain Edema
  • PRIMARY MALIGNANT and METASTATIC BRAIN TUMORS
Intervention  ICMJE Drug: Xerecept
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: June 4, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2009
Estimated Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00691522
Other Study ID Numbers  ICMJE CPDS 0701
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pharmanet
Study Sponsor  ICMJE PharmaNet
Collaborators  ICMJE Celtic Pharma Development Services
Investigators  ICMJE Not Provided
PRS Account PharmaNet
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP