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Sponsored by: |
University of Florida |
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Information provided by: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00717275 |
The purpose of this study is to determine if administering temozolomide after completion of stereotactic radiosurgery helps control existing brain metastases and prevents the developement of new brain metastases.
Condition | Intervention | Phase |
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Brain Metastases |
Drug: Temozolomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Temozolomide (TMZ) Following Stereotactic Radiosurgery (SRS) for Patients With Newly Diagnosed Brain Metastases |
Estimated Enrollment: | 30 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Temozolomide: Experimental |
Drug: Temozolomide
75 mg/m2 taken by mouth once a day for 14 out of 28 consecutive days until progression or unacceptable toxicity.
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Brain metastases represent a heterogenous group of system tumors whose presence in the central nervous system result in profound neurological devastation. Existing therapies for brain metastases are focused on improving both neurologic function and survival. Therapies aimed at controlling the tumor both at the site of the brain metastases and the rest of the brain have the potential to improve outcomes and quality of life. The combined use of stereotactic radiosurgery followed by temozolomide may represent such a strategy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Tumor characteristics adequate for stereotactic radiosurgery:
Systemic parameters adequate for temozolomide following stereotactic radiosurgery:
Exclusion Criteria:
Chemotherapy or other systemic therapy for systemic malignancy within a specified time of temozolomide initiation, depending on half-life of agent:
Contact: Christine Keeling, BSN, OCN | 352.273.7981 | christine.keeling@neurosurgery.ufl.edu |
United States, Florida | |
University of Florida | Recruiting |
Gainesville, Florida, United States, 32610 | |
Contact: Christine Keeling, BSN, OCN 352-273-7981 christine.keeling@neurosurgery.ufl.edu | |
Principal Investigator: Erin M Dunbar, MD |
Principal Investigator: | Erin M Dunbar, MD | University of Florida |
Responsible Party: | University of Florida ( Erin M. Dunbar, MD ) |
Study ID Numbers: | METS-001 |
Study First Received: | July 15, 2008 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00717275 History of Changes |
Health Authority: | United States: Institutional Review Board |
Brain Metastases Temozolomide Temodar |
TMZ Stereotactic Radiosurgery SRS |
Brain Neoplasms Neoplasm Metastasis Central Nervous System Diseases Antineoplastic Agents, Alkylating Central Nervous System Neoplasms |
Brain Diseases Alkylating Agents Temozolomide Nervous System Neoplasms |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Temozolomide Pharmacologic Actions Brain Neoplasms |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site Therapeutic Uses Neoplasm Metastasis Antineoplastic Agents, Alkylating Alkylating Agents Nervous System Neoplasms |