Decitabine and Valproic Acid in Treating Patients With Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial is studying the side effects and best dose of decitabine and valproic acid in treating patients with non-small cell lung cancer. Drugs used in chemotherapy, such as decitabine and valproic acid, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Azacitidine; Decitabine; Valproic Acid

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