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Vorinostat

Histone Deacetylase Inhibitors

Enzyme Inhibitors

Vorinostat will be administered orally once daily in an open-labeled unblinded manner to all subjects enrolled in the study. Subjects will received 400 mg once daily on a continuous daily basis for 7 to 10 days prior to surgical resection.

Vorinostat will be administered orally once daily in an open-labeled, unblinded manner to all subjects enrolled in the study. Subjects will receive vorinostat 400 mg once daily on a continuous daily basis for 7 to 10 days prior to surgical resection. Vorinostat should be taken with food within 0 to 30 minutes of a meal if possible. Patients should take the medication at approximately the same time each day on an ongoing basis. Missed doses will not be made up.

Konstantin H. Dragnev, MD

The primary aim is to study the effects of vorinostat on cyclin E, cyclin D1 and Ki-67 expression in aerodigestive tract tumors (lung, esophagus, and head and neck). Secondary aims are: To evaluate the concentration of vorinostat in tumor tissue and to correlate tumor 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 aerodigestive tract tumors.

A Clinical Trial to Validate Molecular Targets of Vorinostat in Patients With Aerodigestive Tract Cancer

Immunohistochemical score, defined as: 0, no tumor cells staining positive; 1+, 0% to 50% of tumor cells staining positive; 2+, 50% to 75% of tumor cells staining positive; and 3+, 75% to 100% of tumor cells staining positive. The change in the score before and after treatment is percentage - 0-100

Concentration of vorinostat in tumor tissue will be measured after 7 days of use of Vorinostat.

vorinostat's effects on induction of apoptosis or necrosis in treated vs untreated tumors and on p21, p27, EGFR, and phospho-EGFR expression aerodigestive tract tumors. Immunohistochemical score is defined as follows: 0, no tumor cells staining positive; 1+, 0% to 50% of tumor cells staining positive; 2+, 50% to 75% of tumor cells staining positive; and 3+, 75% to 100% of tumor cells staining positive.

Merck Sharp & Dohme LLC

Dartmouth-Hitchcock Medical Center

Staff Physician, Hematology-Oncology

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Patients were asked to take vorinostat for at least 7 days with a maximum of 10 days. Two participants did not follow directions correctly and took the pills for 3 days and 2 days. One participant took medication at 100mg per day and not the 400 mg

Konstnatin Dragnev, MD Professor of Medicine

Changes in Ki-67 expression by immunohistochemical

Changes in cyclin D1 expression by immunohistochem

Changes in cyclin E expression by immunohistochemi

Vorinostat 400 mg once daily orally for 7 to 10 days prior to a second biopsy/ thoracotomy.

Participants who had at least two days days of treatment with vorinostat.

Changes in Tumor Markers on Tumors of the Lung, Esophagus, or Head and Neck, After 7 Days of Treatment With Vorinostat

Vorinostat 400mg one daily administered orally for 7 days prior to a second biopsy/ thoracotomy.

Vorinostat Intratumoral Concentrations

Concentration of Vorinostat in Tumor Tissue

Necrosis

Effects of Vorinostat Treatment on Induction of Apoptosis or Necrosis in Treated vs. Untreated Tumors

Vorinostat 400mg one daily administered orally for 7 to 10 days prior to a second biopsy/ thoracotomy.

Spots Global Cancer Trial Database for aerodigestive tract cancer