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| Sponsor: | Dartmouth-Hitchcock Medical Center |
|---|---|
| Collaborator: |
Merck |
| Information provided by (Responsible Party): | Dartmouth-Hitchcock Medical Center |
| ClinicalTrials.gov Identifier: | NCT00735826 |
Purpose
The primary aim is to study the effects of vorinostat on cyclin E, cyclin D1 and Ki-67 expression in lung, bronchial epithelium, and lung tumors of patients with resectable clinical stage I - III lung cancer. Secondary aims are: To evaluate the concentration of vorinostat in tumor tissue and to correlate lung tissue distribution with the plasma level in these patients; to perform exploratory analyses of the effects of vorinostat on the induction of apoptosis or necrosis in treated as compared to untreated tumors and on expression of p21, p27, EGFR and phospho-EGFR in lung tumors of patients with resectable clinical stage I - III lung cancer; to perform dynamic contrast enhanced CT of the primary tumor to study the effects of treatment on the vascular supply of the tumor and to correlate the results with the intratumoral vorinostat concentrations.
| Condition | Intervention |
|---|---|
|
Non Small Cell Lung Cancer |
Drug: Vorinostat |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | A Clinical Trial to Validate Molecular Targets of Vorinostat in Patients With Stage I-III Non-Small Cell Lung Cancer |
| Estimated Enrollment: | 10 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| Principal Investigator: | Konstantin H. Dragnev, MD | Dartmouth-Hitchcock Medical Center |
More Information
| Responsible Party: | Dartmouth-Hitchcock Medical Center |
| ClinicalTrials.gov Identifier: | NCT00735826 History of Changes |
| Other Study ID Numbers: | D-0828 |
| Study First Received: | August 13, 2008 |
| Last Updated: | December 2, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
resectable stage I-III NSCLC non-small cell lung cancer |
vorinostat proof of principle resectable stage I to III NSCLC |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Vorinostat Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |