Back to resultsPhase I Vorinostat Concurrent With Stereotactic Radiosurgery (SRS) in Brain Metastases From Non-Small Cell Lung Cancer
Primary Purpose
Brain Cancer, Neoplasm Metastasis, Lung Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vorinostat
Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Brain Cancer
Eligibility 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.
Sites / Locations
- Stanford University School of Medicine
- Moffitt Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
vorinostat & stereotactic radiosurgery
Arm Description
Outcomes
Primary Outcome Measures
The maximum tolerated dose of vorinostat with concurrent radiosurgery will be determined.
During the expanded phase I portion of the study, the safety of the Maximum tolerated dose dose will be confirmed.
The radiologic response, defined as local control and distant intra-cranial control rates at 3-months following radiotherapy, will be determined.
Secondary Outcome Measures
The short-term (< 30 days post-treatment) and long-term (> 30 days post-treatment) adverse effects will be determined.
The 12-month survival rate from the date of Stereotactic Radiosurgery will be determined.
Full Information
NCT ID
NCT00946673
First Posted
July 23, 2009
Last Updated
October 4, 2017
Sponsor
Stanford University
Collaborators
National Comprehensive Cancer Network
1. Study Identification
Unique Protocol Identification Number
NCT00946673
Brief Title
Phase I Vorinostat Concurrent With Stereotactic Radiosurgery (SRS) in Brain Metastases From Non-Small Cell Lung Cancer
Official Title
A Phase I Trial of Vorinostat Concurrent With Stereotactic Radiotherapy in Treatment of Brain Metastases From Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Comprehensive Cancer Network
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Cancer, Neoplasm Metastasis, Lung Cancer, Carcinoma, Non-Small-Cell Lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vorinostat & stereotactic radiosurgery
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Vorinostat
Intervention Description
Orally up to 400 mg
Intervention Type
Procedure
Intervention Name(s)
Radiation Therapy
Intervention Description
Single fraction stereotactic radiotherapy - Standard of Care
Primary Outcome Measure Information:
Title
The maximum tolerated dose of vorinostat with concurrent radiosurgery will be determined.
Time Frame
30 days following Stereotactic Radiosurgery
Title
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
Title
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 Measure Information:
Title
The short-term (< 30 days post-treatment) and long-term (> 30 days post-treatment) adverse effects will be determined.
Time Frame
12 months
Title
The 12-month survival rate from the date of Stereotactic Radiosurgery will be determined.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Griffith R. Harsh
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase I Vorinostat Concurrent With Stereotactic Radiosurgery (SRS) in Brain Metastases From Non-Small Cell Lung Cancer
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