- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00691522
Imaging Study of XERECEPT® Treatment for Peritumoral Brain Edema (PBE)
January 8, 2009 updated by: PharmaNet
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
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
Study Overview
Status
Terminated
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Anticipated)
August 1, 2009
Study Completion (Anticipated)
October 1, 2009
Study Registration Dates
First Submitted
June 2, 2008
First Submitted That Met QC Criteria
June 4, 2008
First Posted (Estimate)
June 5, 2008
Study Record Updates
Last Update Posted (Estimate)
January 9, 2009
Last Update Submitted That Met QC Criteria
January 8, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPDS 0701
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peritumoral Brain Edema
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University of PeshawarCompleted
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Xuanwu Hospital, BeijingRecruiting
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Hospital Son EspasesRecruitingTraumatic Brain Injury | Cerebral EdemaSpain
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Qilu Hospital of Shandong UniversityNot yet recruiting
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Ain Shams UniversityCompleted
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Minia UniversityUnknownDiffuse Traumatic Cerebral EdemaEgypt
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B.P. Koirala Institute of Health SciencesRecruitingAcute Mountain Sickness | High Altitude Cerebral Edema | High Altitude Pulmonary EdemaNepal
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Goethe UniversityUnknownAcute Mountain Sickness | High Altitude Cerebral Edema | High Altitude Pulmonary EdemaGermany
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University Hospital, GrenobleUnknownAcute Mountain Sickness | High Altitude Cerebral Edema | High Altitude Pulmonary Edema
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Stanford UniversityWithdrawnCerebral Edema | Saline Solution, HypertonicUnited States
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