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| Sponsor: | Dartmouth-Hitchcock Medical Center |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | 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: | Basic Science, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study |
| 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 2010 (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| Contact: Konstantin H. Dragnev, MD | (603) 650-6345 | konstantin.h.dragnev@hitchcock.org |
| Contact: Brendan M. Slagle, BS | (603) 653-0590 | brendan.m.slagle@dartmouth.edu |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | Recruiting |
| Lebanon, New Hampshire, United States, 03756 | |
| Contact: Brendan M. Slagle, BS (603) 653-0590 brendan.m.slagle@hitchcock.org | |
| Contact: Heidi E. McAllister (603) 650-5475 heidi.e.mcallister@hitchcock.org | |
| Principal Investigator: Konstantin H Dragnev, MD | |
| Sub-Investigator: James R Rigas, MD | |
| Sub-Investigator: David W. Johnstone, MD | |
| Sub-Investigator: Wendye M. DiSalvo, MSN, ARNP, AOCN | |
| Principal Investigator: | Konstantin H. Dragnev, MD | Dartmouth-Hitchcock Medical Center |
More Information
| Responsible Party: | Dartmouth-Hitchcock Medical Center ( Konstantin H. Dragnev, MD ) |
| Study ID Numbers: | D-0828 |
| Study First Received: | August 13, 2008 |
| Last Updated: | March 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00735826 History of Changes |
| 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 |
|
Anticarcinogenic Agents Thoracic Neoplasms Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Respiratory Tract Neoplasms |
Neoplasms by Histologic Type Vorinostat Enzyme Inhibitors Protective Agents Pharmacologic Actions Carcinoma Neoplasms Analgesics, Non-Narcotic Lung Diseases Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |