Trial Outcomes & Findings for A Clinical Trial to Validate Molecular Targets of Vorinostat in Patients With Aerodigestive Tract Cancer (NCT NCT00735826)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Baseline to Day 7

Results posted on

2018-10-12

Participant Flow

Patients with clinical Stage I, II, III A NSCLC or Stage I, II , III esophageal cancer or Stage I, II, III, IV A Head and Neck cancer and a pre-treatment biopsy having at least 3 unstained slides were eligible. Patients were recruited from the oncology clinic.

Participant milestones

Participant milestones
Measure	Vorinostat Vorinostat 400mg one daily administered orally for 7 to 10 days prior to a second biopsy/ thoracotomy.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vorinostat n=10 Participants Vorinostat group
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	67 years STANDARD_DEVIATION 17.33 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Day 7

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

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

Outcome measures

Outcome measures
Measure	Vorinostat n=10 Participants Vorinostat 400 mg once daily orally for 7 to 10 days prior to a second biopsy/ thoracotomy.
Changes in Tumor Markers on Tumors of the Lung, Esophagus, or Head and Neck, After 7 Days of Treatment With Vorinostat Changes in Ki-67 expression by immunohistochemical	67 percentage of change Interval 0.0 to 88.0
Changes in Tumor Markers on Tumors of the Lung, Esophagus, or Head and Neck, After 7 Days of Treatment With Vorinostat Changes in cyclin D1 expression by immunohistochem	40 percentage of change Interval 0.0 to 87.0
Changes in Tumor Markers on Tumors of the Lung, Esophagus, or Head and Neck, After 7 Days of Treatment With Vorinostat Changes in cyclin E expression by immunohistochemi	40 percentage of change Interval 0.0 to 50.0

SECONDARY outcome

Timeframe: Day 7 from Baseline

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

Outcome measures

Outcome measures
Measure	Vorinostat n=10 Participants Vorinostat 400 mg once daily orally for 7 to 10 days prior to a second biopsy/ thoracotomy.
Concentration of Vorinostat in Tumor Tissue	42.6 ng/mg Interval 0.0 to 80.3

SECONDARY outcome

Timeframe: Baseline to day 7

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.

Outcome measures

Outcome measures
Measure	Vorinostat n=10 Participants Vorinostat 400 mg once daily orally for 7 to 10 days prior to a second biopsy/ thoracotomy.
Effects of Vorinostat Treatment on Induction of Apoptosis or Necrosis in Treated vs. Untreated Tumors	1 score on a scale Interval 0.0 to 3.0

Adverse Events

Vorinostat

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Konstnatin Dragnev, MD Professor of Medicine

Dartmouth-Hitchcock Medical Center

Phone: 603-650-6344

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place