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| Name | Class |
|---|---|
| National Comprehensive Cancer Network | NETWORK |
The purpose of this study is to determine the maximum tolerated dose (MTD) of vorinostat given concurrently with stereotactic radiosurgery (SRS) to treat non-small cell lung cancer (NSCLCA) brain metastases in patient with 1-4 lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vorinostat & stereotactic radiosurgery | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vorinostat | Drug | Orally up to 400 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The maximum tolerated dose of vorinostat with concurrent radiosurgery will be determined. | 30 days following Stereotactic Radiosurgery | |
| During the expanded phase I portion of the study, the safety of the Maximum tolerated dose dose will be confirmed. | 30 days following Stereotactic Radiosurgery | |
| The radiologic response, defined as local control and distant intra-cranial control rates at 3-months following radiotherapy, will be determined. | 3 months following Stereotactic Radiosurgery |
| Measure | Description | Time Frame |
|---|---|---|
| The short-term (< 30 days post-treatment) and long-term (> 30 days post-treatment) adverse effects will be determined. | 12 months | |
| The 12-month survival rate from the date of Stereotactic Radiosurgery will be determined. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Patients who have previously been treated with whole brain irradiation, pediatric patients (age <18), pregnant women, and patients who are unable to give informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Griffith R. Harsh | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States | ||
| Moffitt Cancer Center |
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| Radiation Therapy |
| Procedure |
Single fraction stereotactic radiotherapy - Standard of Care |
|
| Tampa |
| Florida |
| 33612 |
| United States |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D009362 | Neoplasm Metastasis |
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D000077337 | Vorinostat |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D013812 | Therapeutics |
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