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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT00821951
Phase
PHASE1
Status
Completed

Conditions

  • Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vorinostat — DRUG
    200 mg, 300 mg, 400 mg, once per RT fraction
  • Radiotherapy — RADIATION
    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.

Study Details

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.

Key Dates

Start date
May 31, 2009
Status verified
Nov 2020
Primary completion
Jul 31, 2012
Completion
Jul 31, 2012

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Vorinostat and Radiotherapy

Primary Outcome Measure

The Primary Endpoint of the Study is to Establish the Maximum Tolerated Dose of Vorinostat When Given Concurrently With Palliative Radiation. [ Time Frame: 1 Year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yale University School of MedicineNew HavenConnecticut06520-

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Yale University School of Medicine· New Haven, CT

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