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A Clinical Trial to Validate Molecular Targets of Vorinostat in Patients With Stage I-III Non-Small Cell Lung Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

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Trial Information

A Clinical Trial to Validate Molecular Targets of Vorinostat in Patients With Stage I-III Non-Small Cell Lung Cancer


Inclusion Criteria:



- All patients must have pathological confirmation of non small cell lung cancer.

- Patients must have resectable clinical stage I - III non small cell lung cancer as
defined by the current International Staging System for Lung Cancer.

- Age >18 years.

- Adequate hepatic and renal function documented prior to study entry to include:
hepatic transaminases (AST or ALT) ≤ 2.0 times the upper limits of normal, total
bilirubin ≤ 1.5 times the upper limits of normal, serum creatinine ≤ 1.5 times the
upper limit of normal or estimated creatinine clearance ≥ 60 mL/min.

- All patients must be medical candidates for surgical resection of their non-small
cell lung cancer.

- All patients must give informed consent indicating they are aware of the
investigational nature of this treatment.

Exclusion Criteria:

- Patients may not have received radiation therapy for their non-small cell lung
cancer.

- Patients may not have received chemotherapy for their non-small cell lung cancer.

- Women must be surgically sterilized or post-menopausal or women of childbearing
potential must be using an adequate method of contraception. Women of childbearing
potential must be using at least one of the following: oral, implanted, injectable
contraceptive hormones, or mechanical products such as an intrauterine device or
barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing
abstinence or have a partner that is sterile (e.g., vasectomy). Women of
childbearing potential must have a negative serum or urine pregnancy test within 72
hours prior to start of study therapy.

- Women who are pregnant or breast-feeding will be excluded.

- Male patients with partners of childbearing potential not using an adequate method of
birth control as described in the previous paragraph will be excluded.

- Patients with gastrointestinal abnormalities including: inability to take oral
medication, requirement for intravenous alimentation, or prior surgical procedures
affecting absorption will be excluded.

- A serious uncontrolled medical disorder or active infection which would impair their
ability to receive study treatment will be excluded. Significant cardiac disease,
including uncontrolled high blood pressure, unstable angina, congestive heart
failure, myocardial infarction within the previous 3 months or serious cardiac
arrythmias will be excluded. Dementia or significantly altered mental status that
would prohibit the understanding or rendering of informed consent and compliance with
the requirements of this protocol will be excluded.

- Patients with active HIV, HCV or HCB infection.

- No prior treatment with HDAC inhibitors. Valproic acid is acceptable if not used as
anticancer therapy and a 30-day wash-out period is allowed.

- Exposure to other investigational agents within 30 days of study inclusion

- Patients with a "currently active" second malignancy, other than nonmelanoma skin
cancer and carcinoma in situ of the cervix, should not be enrolled. Patients would
not be considered to have a "currently active" malignancy if they have completed
therapy for a prior malignancy, are disease free from prior malignancies for >5 years
or are considered by their physician to be at less than 30% risk of relapse.

- Patients with history of pulmonary embolism who are not receiving anticoagulation,
will be excluded.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

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.

Outcome Time Frame:

This will be determined once all of the data has been collected and analyzed

Safety Issue:

No

Principal Investigator

Konstantin H. Dragnev, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center

Authority:

United States: Institutional Review Board

Study ID:

D-0828

NCT ID:

NCT00735826

Start Date:

March 2009

Completion Date:

Related Keywords:

  • Non Small Cell Lung Cancer
  • 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

Name

Location

Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756