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| Sponsor: | PharmaNet |
|---|---|
| Collaborator: |
Celtic Pharma Development Services |
| Information provided by: | PharmaNet |
| ClinicalTrials.gov Identifier: | NCT00691522 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Peritumoral Brain Edema PRIMARY MALIGNANT and METASTATIC BRAIN TUMORS |
Drug: Xerecept |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
• Low-grade gliomas, recurrent gliomas, suspected lymphoma, or known human immunosuppressive virus (HIV) infection.
Contacts and Locations
More Information
| Responsible Party: | Pharmanet |
| ClinicalTrials.gov Identifier: | NCT00691522 History of Changes |
| Other Study ID Numbers: | CPDS 0701 |
| Study First Received: | June 2, 2008 |
| Last Updated: | January 8, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
PERITUMORAL BRAIN EDEMA PRIMARY MALIGNANT BRAIN TUMORS METASTATIC BRAIN TUMORS |
|
Brain Edema Brain Neoplasms Edema Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Neoplasms Nervous System Neoplasms |
Neoplasms by Site Neoplasms Signs and Symptoms Corticotropin-Releasing Hormone Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |