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

This study has been terminated.

Sponsor:

Collaborator:

Celtic Pharma Development Services

Information provided by:

PharmaNet

ClinicalTrials.gov Identifier:

NCT00691522

First received: June 2, 2008

Last updated: January 8, 2009

Last verified: January 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	June 2, 2008
Last Updated Date	January 8, 2009
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Peritumoral Brain Edema PRIMARY MALIGNANT and METASTATIC BRAIN TUMORS
Intervention ^ICMJE	Drug: Xerecept
Study Arm (s)	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	60
Estimated Completion Date	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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00691522
Other Study ID Numbers ^ICMJE	CPDS 0701
Has Data Monitoring Committee	No
Responsible Party	Pharmanet
Study Sponsor ^ICMJE	PharmaNet
Collaborators ^ICMJE	Celtic Pharma Development Services
Investigators ^ICMJE	Not Provided
Information Provided By	PharmaNet
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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