Phase I Study of Induction Therapy With VELCADE and Vorinostat in Patients With Surgically Resectable Non-Small Cell Lung Cancer
- Registration Number
- NCT00731952
- Lead Sponsor
- University of Virginia
- Brief Summary
The purpose of this study is to find out what effects (both good and bad) two medications (VELCADE and Vorinostat) have on patients who have certain types of lung cancer. The study is "dose escalating" meaning that patients will receive different doses of medication depending on when they enter the study. Participation in the study will last approximately 3 months and will include an initial screening visit, a visit once each week for 3 weeks to receive the study medications, and then 2 additional visits around the time of your surgery to remove your lung cancer tumor.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Velcade and Vorinostat Velcade and Vorinostat Subjects will receive one of 3 doses of Velcade (at a dose of 1.0 - 1.6 mg/m2 once weekly for 3 weeks) and one of 4 doses of Vorinostat (at a dose of 100mg every day 3 times a week for 3 weeks to 300mg twice per day, 3 times per week for 3 weeks). Doses determined by a predetermined escalation schedule.
- Primary Outcome Measures
Name Time Method Adverse events 30 days post surgical resection
- Secondary Outcome Measures
Name Time Method Tumor response Day 22
Trial Locations
- Locations (1)
University of Virginia
🇺🇸Charlottesville, Virginia, United States