Phase I Vorinostat Concurrent With Stereotactic Radiosurgery (SRS) in Brain Metastases From Non-Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT00946673 |
Recruitment Status :
Completed
First Posted : July 27, 2009
Last Update Posted : October 6, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain Cancer Neoplasm Metastasis Lung Cancer Carcinoma, Non-Small-Cell Lung | Drug: Vorinostat Procedure: Radiation Therapy | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 17 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Trial of Vorinostat Concurrent With Stereotactic Radiotherapy in Treatment of Brain Metastases From Non-Small Cell Lung Cancer |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | July 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: vorinostat & stereotactic radiosurgery |
Drug: Vorinostat
Orally up to 400 mg Procedure: Radiation Therapy Single fraction stereotactic radiotherapy - Standard of Care |
- The maximum tolerated dose of vorinostat with concurrent radiosurgery will be determined. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 3 months following Stereotactic Radiosurgery ]
- The short-term (< 30 days post-treatment) and long-term (> 30 days post-treatment) adverse effects will be determined. [ Time Frame: 12 months ]
- The 12-month survival rate from the date of Stereotactic Radiosurgery will be determined. [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All patients age 18 years and older with histologically proven non-small cell lung cancer and 1-4 brain metastases, each measuring less than 2 cm will be eligible. Prior surgery or radiation is allowed as long as the target metastatic lesion(s) has not been treated with previous radiation.
- Adequate organ function (section 3.1.10).
- ECOG performance status 0-2.
- Life expectancy of >=12 weeks.
- Systemic chemotherapy washout period >=7 days.
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946673
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 | |
United States, Florida | |
Moffitt Cancer Center | |
Tampa, Florida, United States, 33612 |
Principal Investigator: | Griffith R. Harsh | Stanford University |
Responsible Party: | Griffith R Harsh, Professor of Neurosurgery, Stanford University |
ClinicalTrials.gov Identifier: | NCT00946673 |
Other Study ID Numbers: |
LUN0036 |
First Posted: | July 27, 2009 Key Record Dates |
Last Update Posted: | October 6, 2017 |
Last Verified: | October 2017 |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Neoplasm Metastasis Brain Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Neoplastic Processes Pathologic Processes Central Nervous System Neoplasms Nervous System Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Vorinostat Antineoplastic Agents Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |