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

Lung Cancer Clinical Trial

Official title:

A Phase I Trial of Vorinostat Concurrent With Stereotactic Radiotherapy in Treatment of Brain Metastases From Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00946673
• Other study ID #: LUN0036
• Status: Completed
• Phase: Phase 1
• First received: July 23, 2009
• Last updated: October 4, 2017
• Start date: June 2009
• Est. completion date: July 2015

Study information

• Verified date: October 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Cancer
• Brain Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• Vorinostat
Orally up to 400 mg

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Comprehensive Cancer Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum tolerated dose of vorinostat with concurrent radiosurgery will be determined.		30 days following Stereotactic Radiosurgery
Primary	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
Primary	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	The short-term (< 30 days post-treatment) and long-term (> 30 days post-treatment) adverse effects will be determined.		12 months
Secondary	The 12-month survival rate from the date of Stereotactic Radiosurgery will be determined.		12 months