This trial is active, not recruiting.

Conditions brain cancer, neoplasm metastasis, lung cancer, carcinoma, non-small-cell lung
Treatments vorinostat, radiation therapy
Phase phase 1
Target HDAC
Sponsor Stanford University
Collaborator National Comprehensive Cancer Network
Start date June 2009
End date July 2014
Trial size 26 participants
Trial identifier NCT00946673, LUN0036


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Orally up to 400 mg
radiation therapy
Single fraction stereotactic radiotherapy - Standard of Care

Primary Outcomes

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
he 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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Phase I Trial of Vorinostat Concurrent With Stereotactic Radiotherapy in Treatment of Brain Metastases From Non-Small Cell Lung Cancer
Principal investigator Griffith R. Harsh
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Stanford University.