Phase I Vorinostat Concurrent With Stereotactic Radiosurgery (SRS) in Brain Metastases From Non-Small Cell Lung Cancer
A Phase I Trial of Vorinostat Concurrent With Stereotactic Radiotherapy in Treatment of Brain Metastases From Non-Small Cell Lung Cancer
1 other identifier
interventional
17
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2009
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 23, 2009
CompletedFirst Posted
Study publicly available on registry
July 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedOctober 6, 2017
October 1, 2017
5.1 years
July 23, 2009
October 4, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
The maximum tolerated dose of vorinostat with concurrent radiosurgery will be determined.
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.
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.
3 months following Stereotactic Radiosurgery
Secondary Outcomes (2)
The short-term (< 30 days post-treatment) and long-term (> 30 days post-treatment) adverse effects will be determined.
12 months
The 12-month survival rate from the date of Stereotactic Radiosurgery will be determined.
12 months
Study Arms (1)
vorinostat & stereotactic radiosurgery
EXPERIMENTALInterventions
Single fraction stereotactic radiotherapy - Standard of Care
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Comprehensive Cancer Networkcollaborator
Study Sites (2)
Stanford University School of Medicine
Stanford, California, 94305, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Griffith R. Harsh
Stanford University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurosurgery
Study Record Dates
First Submitted
July 23, 2009
First Posted
July 27, 2009
Study Start
June 1, 2009
Primary Completion
July 1, 2014
Study Completion
July 1, 2015
Last Updated
October 6, 2017
Record last verified: 2017-10