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

A Phase I Trial of Vorinostat Concurrent With Stereotactic Radiotherapy in Treatment of Brain Metastases From Non-Small Cell Lung Cancer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00946673

Enrollment

Registered

2009-07-27

Start date

2009-06-30

Completion date

2015-07-31

Last updated

2017-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Cancer, Carcinoma, Non-Small-Cell Lung, Lung Cancer, Neoplasm Metastasis

Brief summary

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.

Interventions

DRUGVorinostat

Orally up to 400 mg

PROCEDURERadiation Therapy

Single fraction stereotactic radiotherapy - Standard of Care

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
The maximum tolerated dose of vorinostat with concurrent radiosurgery will be determined.	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.	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.	3 months following Stereotactic Radiosurgery

Secondary

Measure	Time frame
The short-term (< 30 days post-treatment) and long-term (> 30 days post-treatment) adverse effects will be determined.	12 months
The 12-month survival rate from the date of Stereotactic Radiosurgery will be determined.	12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026