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

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ClinicalTrials.gov Identifier: NCT00946673
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : October 6, 2017
Sponsor:
Collaborator:
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Griffith R Harsh, Stanford University

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
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
Study Start Date : June 2009
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Vorinostat

Arms and Interventions
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Arm Intervention/treatment
Experimental: vorinostat & stereotactic radiosurgery Drug: Vorinostat
Orally up to 400 mg

Procedure: Radiation Therapy
Single fraction stereotactic radiotherapy - Standard of Care


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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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
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Principal Investigator: Griffith R. Harsh Stanford University
More Information
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Responsible Party: Griffith R Harsh, Professor of Neurosurgery, Stanford University
ClinicalTrials.gov Identifier: NCT00946673    
Other Study ID Numbers: LUN0036
First Posted: July 27, 2009    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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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