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Sponsors and Collaborators: |
University of Utah Novartis |
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Information provided by: | University of Utah |
ClinicalTrials.gov Identifier: | NCT00813592 |
This is a single-arm, phase II trial of SOM230 in patients with documented recurrent or progressive intracranial meningioma who have failed conventional therapy and are not candidates for complete surgical resection of their tumors and/or radiation at the time of study entry.
At the time of the final analysis, all patients who are receiving treatment with SOM230 will complete the core phase of the study and will continue on the extension phase. During this time, additional data on response duration, PFS, and safety will be collected.
Condition | Intervention | Phase |
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Cancer |
Drug: SOM230B |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | A Phase II Study of SOM230 in Patients With Recurrent or Progressive Meningioma Who Have Previously Undergone or Are Not Candidates for Additional Surgery or Radiation |
Estimated Enrollment: | 42 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5.
Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Utah | |
Huntsman Cancer Institute | |
Salt Lake City, Utah, United States, 84112 |
Principal Investigator: | Michael Glantz, MD | University of Utah |
Responsible Party: | Huntsman Cancer Institute ( Michael Glantz, MD ) |
Study ID Numbers: | 26519 |
Study First Received: | November 17, 2008 |
Last Updated: | April 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00813592 History of Changes |
Health Authority: | United States: Food and Drug Administration |
meningioma brain |
Meningeal Neoplasms Meningioma Central Nervous System Neoplasms Hormones |
Somatostatin Nervous System Neoplasms Recurrence |
Meningeal Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Nervous System Diseases |
Neoplasms, Nerve Tissue Neoplasms, Vascular Tissue Meningioma Central Nervous System Neoplasms Nervous System Neoplasms |