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| Sponsor: | University of Florida |
|---|---|
| Information provided by (Responsible Party): | University of Florida |
| ClinicalTrials.gov Identifier: | NCT00717275 |
Purpose
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 |
|---|---|---|
|
Brain Metastases |
Drug: Temozolomide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Temozolomide (TMZ) Following Stereotactic Radiosurgery (SRS) for Patients With Newly Diagnosed Brain Metastases |
| Enrollment: | 3 |
| Study Start Date: | September 2008 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Temozolomide |
Drug: Temozolomide
75 mg/m2 taken by mouth once a day for 14 out of 28 consecutive days until progression or unacceptable toxicity.
Other Names:
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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.
Eligibility| 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:
Contacts and Locations| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| Principal Investigator: | Erin M Dunbar, MD | University of Florida |
More Information
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT00717275 History of Changes |
| Other Study ID Numbers: | METS-001 |
| Study First Received: | July 15, 2008 |
| Last Updated: | September 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Brain Metastases Temozolomide Temodar |
TMZ Stereotactic Radiosurgery SRS |
|
Neoplasm Metastasis Neoplasms, Second Primary Brain Neoplasms Neoplastic Processes Neoplasms Pathologic Processes Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |