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

Completed · Phase 1

Conditions studied: Recurrent Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00084981

Run by

National Cancer Institute (NCI)

People needed

25

Starts

2004-04-01

Last updated by the study team

2013-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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