Skip to main content
OpenTrials
Completed

NCT Number: NCT00946673

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brain Cancer Brain Diseases Brain Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Central Nervous System Diseases Central Nervous System Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University School of Medicine, Stanford, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vorinostat

Drug

Orally up to 400 mg

Radiation Therapy

Procedure

Single fraction stereotactic radiotherapy - Standard of Care

Primary outcomes

  1. The maximum tolerated dose of vorinostat with concurrent radiosurgery will be determined.

    Time frame: 30 days following Stereotactic Radiosurgery

  2. 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

  3. 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

Secondary outcomes

  1. The short-term (< 30 days post-treatment) and long-term (> 30 days post-treatment) adverse effects will be determined.

    Time frame: 12 months

  2. The 12-month survival rate from the date of Stereotactic Radiosurgery will be determined.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Comprehensive Cancer Network

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2015
First posted
Jul 27, 2009
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.