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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00946673

First Posted: July 27, 2009

Last Update Posted: October 6, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

National Comprehensive Cancer Network

Information provided by (Responsible Party):

Griffith R Harsh, Stanford University

Purpose

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.

Condition	Intervention	Phase
Brain Cancer Neoplasm Metastasis Lung Cancer Carcinoma, Non-Small-Cell Lung	Drug: Vorinostat Procedure: Radiation Therapy	Phase 1


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	A Phase I Trial of Vorinostat Concurrent With Stereotactic Radiotherapy in Treatment of Brain Metastases From Non-Small Cell Lung Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Vorinostat

U.S. FDA Resources

Further study details as provided by Griffith R Harsh, Stanford University:

Primary Outcome Measures:

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 ]
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 Outcome Measures:

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 ]


Enrollment:	17
Study Start Date:	June 2009
Study Completion Date:	July 2015
Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: vorinostat & stereotactic radiosurgery	Drug: Vorinostat Orally up to 400 mg Procedure: Radiation Therapy Single fraction stereotactic radiotherapy - Standard of Care

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946673

Locations


United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612

Sponsors and Collaborators

Stanford University

National Comprehensive Cancer Network

Investigators


Principal Investigator:	Griffith R. Harsh	Stanford University

More Information


Responsible Party:	Griffith R Harsh, Professor of Neurosurgery, Stanford University
ClinicalTrials.gov Identifier:	NCT00946673 History of Changes
Other Study ID Numbers:	LUN0036
First Submitted:	July 23, 2009
First Posted:	July 27, 2009
Last Update Posted:	October 6, 2017
Last Verified:	October 2017

Additional relevant MeSH terms:


Lung Neoplasms Carcinoma, Non-Small-Cell Lung Neoplasm Metastasis Brain Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms	Neoplastic Processes Pathologic Processes Central Nervous System Neoplasms Nervous System Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Vorinostat Antineoplastic Agents Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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