Griffith Harsh
Phase I Vorinostat Concurrent with Stereotactic Radiosurgery (SRS) in Brain Metastases from Non-Small Cell Lung Cancer
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Vorinostat
- Procedure: Radiation Therapy
Phase:
Phase 1Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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.
Key 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.
Additional Study Details
Official Title:
A Phase I Trial of Vorinostat Concurrent with Stereotactic Radiotherapy in Treatment of Brain Metastases from Non-Small Cell Lung CancerAnticipated start date:
6/22/2009Lead Sponsor:
Stanford UniversityCollaborator(s):
- National Comprehensive Cancer Network
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
UnspecifiedPrimary Outcomes:
- The safety of the MTD of vorinostat concurrent with radiotherapy will be confirmed.
- The radiologic response, defined as local control and distant intra-cranial control rates at 3-months following radiotherapy, will be determined.
- The MTD and DLT of daily vorinostat concurrent with SRS will be determined.
Secondary Outcomes:
- 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 SRS will be determined.
Total Number to be Enrolled:
26Total Number to be Enrolled at Stanford:
26More Information
Secondary ID(s):
- LUN0036
- NCT00946673
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
7/30/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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