Phase I Vorinostat Concurrent With Stereotactic Radiosurgery (SRS) in Brain Metastases From Non-Small Cell Lung Cancer

Completed · Phase 1

Conditions studied: Brain Cancer, Neoplasm Metastasis, Lung Cancer, Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID

NCT00946673

Run by

Stanford University

People needed

17

Starts

2009-06-01

Expected to finish

2015-07-01

Last updated by the study team

2017-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford University School of Medicine — Stanford, California, United States
• Moffitt Cancer Center — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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