NCT00821951

Vorinostat in Combination With Palliative Radiotherapy for Patients With Non-Small Cell Lung Cancer

A Dose Escalation Study of Vorinostat in Combination With Palliative Radiotherapy for Patients With Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a dose escalation study that will assess the safety of Vorinostat, a Histone Deacetylase (HDAC) inhibitor, in combination with palliative radiotherapy in patients with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). Vorinostat has been approved for use in patients with cutaneous T-cell lymphomas, but several pre-clinical studies suggest activity in lung cancer cell lines. Several HDAC inhibitors,including Vorinostat, may enhance the effect of radiotherapy, and this study will seek to confirm this.

Conditions

• Non-Small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	Vorinostat	200 mg, 300 mg, 400 mg, once per RT fraction
RADIATION	Radiotherapy	Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated.

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2009-01-14
• Last updated: 2020-11-20
• Results posted: 2013-01-17

Locations

1 site across 1 country: United States