A Phase 1 interventional study of Vorinostat and Radiation Therapy in Brain Cancer, Neoplasm Metastasis and Lung Cancer, sponsored by Stanford University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-06.
Sponsored by Stanford University · Phase 1, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 17 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Drug: Vorinostat · Procedure: Radiation Therapy
Orally up to 400 mg
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
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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