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

Stanford University

Status and phase

Completed

Phase 1

Conditions

Carcinoma, Non-Small-Cell Lung

Lung Cancer

Neoplasm Metastasis

Brain Cancer

Treatments

Procedure: Radiation Therapy

Drug: Vorinostat

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT00946673

LUN0036

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.