Decitabine and Valproic Acid in Treating Patients With Non-Small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

About this trial
This is an interventional treatment trial for Recurrent Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed non-small cell lung cancer Tumor accessible to biopsy by bronchoscopy, through surface biopsy (e.g., skin punch biopsy for skin/subcutaneous metastasis) or through CT scan guidance Not eligible for curative surgery, chemotherapy, radiotherapy, or multimodality treatment options No uncontrolled brain metastases Controlled brain metastases allowed provided patient has no neurologic deterioration when off steroids; has completed prior radiotherapy or other treatments; has fully recovered from prior treatment; and does not require anticonvulsants Performance status - ECOG 0-2 Performance status - Karnofsky 60-100% More than 12 weeks Absolute neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 WBC > 3,000/mm^3 AST and ALT =< 2.5 times upper limit of normal (ULN) Bilirubin =< 1.5 times ULN Creatinine =< 1.5 times ULN Creatinine clearance >= 60 mL/min No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior allergic reaction to compounds of similar chemical or biological composition to decitabine, valproic acid, or other study agents No other concurrent uncontrolled illness No ongoing or active infection requiring antibiotics No history of seizures requiring anticonvulsants No medical problem that would preclude study participation No psychiatric illness or social situation that would preclude study compliance No other active malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF] or epoetin alfa) No more than 3 prior chemotherapy regimens More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Prior definitive radiotherapy to the chest allowed Clinical (radiographic or other) evidence of tumor progression for previously irradiated indicator lesion in the chest More than 2 weeks since prior radiotherapy and recovered No concurrent palliative radiotherapy Prior curative or palliative intent surgery allowed At least 2 weeks since prior surgery and recovered At least 4 weeks since prior photodynamic therapy No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent anticancer agents or therapies No other concurrent investigational agents No concurrent administration of any of the following medications: Aspirin Chronic low-dose (=< 81 mg/day) aspirin allowed Felbamate Rifampin Amitriptyline Nortriptyline Carbamazepine Clonazepam Diazepam Ethosuximide Lamotrigine Phenobarbital Barbiturates Primidone Phenytoin Zidovudine No concurrent divalproex sodium Concurrent gabapentin for neuropathic pain allowed
Sites / Locations
- Ohio State University Medical Center
Arms of the Study
Arm 1
Experimental
Treatment (decitabine, valproic acid)
Patients receive decitabine IV over 1 hour on days 1-10 and oral valproic acid three times daily on days 5-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of decitabine and valproic acid until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After the MTD is determined, an additional 6 patients are treated at that dose.