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
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
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
NCT ID
NCT00691522
First Posted
June 2, 2008
Last Updated
January 8, 2009
Sponsor
PharmaNet
Collaborators
Celtic Pharma Development Services
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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