Azacitidine and Entinostat in Treating Patients With Newly Diagnosed Stage IA-IIIA Non-Small Lung Cancer Undergoing Surgery

Stopped early · Phase 1

Conditions studied: Stage IA Non-Small Cell Lung Carcinoma, Stage IB Non-Small Cell Lung Carcinoma, Stage IIA Non-Small Cell Lung Carcinoma, Stage IIB Non-Small Cell Lung Carcinoma, Stage IIIA Non-Small Cell Lung Cancer

In brief

This pilot clinical trials studies azacitidine and entinostat in treating patients with newly diagnosed stage IA-IIIIA non-small cell lung undergoing surgery. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Entinostat may stop the growth of cancer tumor cells by blocking some of the enzymes needed for cell growth. Giving azacitidine with entinostat may be an effective treatment for non-small cell lung cancer.

Key facts

Study ID: NCT01886573
Run by: National Cancer Institute (NCI)
People needed: 40
Starts: 2013-06-01
Expected to finish: 2015-02-01
Last updated by the study team: 2016-11-18

Who can join

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

You may qualify if…

Undergoing a diagnostic biopsy, including computed tomography (CT)-guided or bronchoscopic for suspected diagnosis of NSCLC
Able to understand and sign an informed consent discussing the risks and benefits of obtaining a concurrent research biopsy; patients who have a fresh frozen biopsy available secondary to institutional tissue collection protocols may substitute such a biopsy for the study-required pre-treatment biopsy
Histologically confirmed diagnosis of operable NSCLC that has not been previously treated
Clinical stage IA-IIIA
Appropriate candidate for surgical management, in the opinion of the treating thoracic surgeon
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 at the time of initiation of neoadjuvant epigenetic therapy
Absolute neutrophil count > 1,000/mcL
Platelets > 100,000/mcL
Total bilirubin < 1.5 x institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x institutional ULN
Creatinine < 1.5 x institutional ULN
Able to understand and sign an informed consent
Women of child-bearing potential and 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
Inclusion of women and minorities:
Both men and women and members of all races and ethnic groups are eligible for this trial; the coordinating center will be responsible for ensuring each participating site is accruing a representative sample consistent with the estimate of population representation in the site's geographical location for race and ethnic groups as determined by the Census Bureau to assure overall target goals are met

You may not qualify if…

Patients who have received prior chemotherapy or radiation for their diagnosis of lung cancer
Patients may not be receiving any other investigational agent
History of allergic reactions attributed to compounds of similar chemical or biologic composition to entinostat or 5-azacytidine
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated on this protocol
Any co-morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
Human immunodeficiency virus (HIV) positive patients on combination antiretroviral therapy are ineligible
Known or suspected hypersensitivity to azacitidine or mannitol
Patients with advanced malignant hepatic tumors
Use of anti-neoplastic or anti-tumor agents that are not part of the study therapy, including chemotherapy, radiation therapy, immunotherapy, and hormonal anticancer therapy, is not permitted while participating in this study; Note: study participants with stage II or III NSCLC, or stage I NSCLC with tumor size greater than 4 cm, should be offered standard adjuvant platinum-based chemotherapy in accordance with local practice (post-operatively)

Where it is running

University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
University of New Mexico — Albuquerque, New Mexico, United States
University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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