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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Brigham and Women's Hospital Massachusetts General Hospital Novartis |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00859040 |
The purpose of this research study is to evaluate the effectiveness and safety of SOM230C in treating recurrent meningiomas. SOM230C is a newly discovered drug that may stop meningioma cells from growing abnormally. This drug has been used in treatment of other tumors, and information from those other research studies suggests that SOM230C may help to stop the growth of meningiomas.
Condition | Intervention | Phase |
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Meningioma |
Drug: SOM230C |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Monthly SOM230C for Recurrent or Progressive Meningioma |
Estimated Enrollment: | 40 |
Study Start Date: | March 2009 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Therefore, each treatment cycle lasts 28 days.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Participants without histological confirmation but a classic radiographic picture of meningioma may also enroll if the tumor is not surgically accessible. Patients with neurofibromatosis type 2 and a classic radiographic picture of meningioma may also enroll without histological confirmation
Exclusion Criteria:
Contact: Patrick Y. Wen, MD | 617-632-2166 | pwen@partners.org |
Contact: Samantha Hammond | 617-632-5396 |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Sceppa Christine, BA 617-632-6684 Christine_Sceppa@DFCI.harvard.edu | |
Principal Investigator: Patrick Y. Wen, MD | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Nancy Shearer, RN 617-726-7851 nshearer@partners.org | |
Principal Investigator: Scott R. Plotkin, MD, PhD | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | Not yet recruiting |
New York, New York, United States, 10065 | |
Contact: Lauren Abrey, M.D. 212-639-5122 abreyl@MSKCC.org | |
United States, North Carolina | |
Wake Forest University Baptist Medical Center | Not yet recruiting |
Winston-Salem, North Carolina, United States, 27157 | |
Contact: Glenn Lesser, MD 336-716-9527 glesser@wfubmc.edu |
Principal Investigator: | Patrick Y. Wen, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( Patrick Wen, MD ) |
Study ID Numbers: | 08-266, CSOM230CUS09T |
Study First Received: | March 9, 2009 |
Last Updated: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00859040 History of Changes |
Health Authority: | United States: Food and Drug Administration |
recurrent intracranial meningioma(s) progressive intracranial meningioma(s) |
Meningeal Neoplasms Meningioma Central Nervous System Neoplasms 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 |