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

This study is currently recruiting participants.

Verified February 2012 by Stanford University

First Received on July 23, 2009. Last Updated on February 2, 2012 History of Changes

Sponsor:	Griffith R Harsh
Collaborator:	National Comprehensive Cancer Network
Information provided by (Responsible Party):	Griffith R Harsh, Stanford University
ClinicalTrials.gov Identifier:	NCT00946673

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:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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:

MedlinePlus related topics: Brain Cancer Cancer Lung Cancer

Drug Information available for: Vorinostat

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

The maximum tolerated dose of vorinostat with concurrent radiosurgery will be determined. [ Time Frame: 30 days following Stereotactic Radiosurgery ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
The 12-month survival rate from the date of Stereotactic Radiosurgery will be determined. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	26
Study Start Date:	June 2009
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Orally up to 400 mg

Single fraction stereotactic radiotherapy - Standard of Care

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946673

Contacts

Contact: Maria Coburn

(650) 736-9551

mcoburn@stanford.edu

Locations

United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Maria Coburn 650-736-9551 mcoburn@stanford.edu
Contact: Cancer Clinical Trials Office (650) 498-7061
Sub-Investigator: Clara Choi
Sub-Investigator: Iris Catrice Gibbs
Sub-Investigator: Scott Soltys
Sub-Investigator: Heather A. Wakelee
Principal Investigator: Griffith R. Harsh
United States, Florida
Moffitt Cancer Center	Recruiting
Tampa, Florida, United States, 33612
Contact: Melissa Joiner, RN, CCRC 813-745-1896 Melissa.joiner@moffitt.org@moffitt.org
Principal Investigator: Mary Pinder-Schenck, MD

Sponsors and Collaborators

Griffith R Harsh

National Comprehensive Cancer Network

Investigators

Principal Investigator:

Griffith R. Harsh

Stanford University

More Information

No publications provided

Responsible Party:	Griffith R Harsh, Professor, Stanford University
ClinicalTrials.gov Identifier:	NCT00946673 History of Changes
Other Study ID Numbers:	LUN0036
Study First Received:	July 23, 2009
Last Updated:	February 2, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Brain Neoplasms
Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Vorinostat
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 24, 2012