Vorinostat in Combination With Palliative Radiotherapy for Patients With Non-Small Cell Lung Cancer

Inclusion Criteria

• •Eligibility Criteria
• •Patients must have histologically or cytologically confirmed NSCLC. Patients must have metastatic disease, stage IIIB with malignant pleural effusion, or be otherwise unsuitable for potentially curative therapy due to bulk of disease or comorbid medical illness. There must be disease apparent on imaging which offers a medical indication for radiation therapy. Palliative radiotherapy would be offered as appropriate standard therapy outside of a study setting. (NOTE: Radiotherapy utilized in this regimen is the same as that which would be offered as standard treatment outside of this study). Indications for palliative radiation include pain, pathologic fracture or risk of fracture, lymphovascular obstruction, bronchial obstruction, neural impingement, dyspnea, or bleeding.
• •There must be a measurable tumor target (visible, palpable, or radiographically evident) for palliative radiation. The target for radiotherapy must be in the thoracic region (i.e., there must be normal lung tissue at the same anatomic level).
• •Age ≥18 years. Because no dosing or adverse event data are currently available on the use of vorinostat alone, or in combination radiation in patients \<18 years of age, children are excluded from this study.
• •ECOG performance status ≤3
• •Life expectancy of greater 3 months.
• •Patients must have normal organ and marrow function as defined below, all laboratory values to be obtained within 2 weeks prior to enrollment:
• •absolute neutrophil count ≥1,500/mcL
• •platelets ≥100,000/mcL
• •hemoglobin ≥9 g/ dL
• •serum bilirubin \<1.5 times the upper limit of normal (ULN) serum AST, ALT, ALP \<2.5 times ULN
• •serum Creatinine \<1.5 times ULN
• •serum Potassium, Magnesium, Calcium - within normal range
• •The effects of radiation on the developing human fetus are known to be teratogenic. For this reason, women of child-bearing potential and sexually active men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• •Ability to understand and the willingness to sign a written informed consent document.
• •Ability to swallow a capsule
• •Patients must have had a CT scan of the chest, abdomen, and pelvis (or PET/CT of the body), as well as an MRI or contrasted CT of the brain within 30 days of enrollment