Overview

Azacitidine and Entinostat in Treating Patients With Stage I Non-Small Cell Lung Cancer That Has Been Removed By Surgery

Status:
Terminated
Trial end date:
2013-05-01
Target enrollment:
0
Participant gender:
All
Summary
This study combines the deoxyribonucleic acid (DNA) methyltransferase inhibitor, 5-azacitidine (5-AZA), with an orally bioavailable histone deacetylase inhibitor, entinostat (SNDX-275), for the adjuvant treatment of patients with resected stage I non-small cell lung cancer (NCSLC).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Azacitidine
Entinostat
Histone Deacetylase Inhibitors
Criteria
Inclusion Criteria:

- Patients must be status post complete (R0) surgical resection of pathologically-proven
NSCLC (stage IA-IB according to AJCC version 7)

- Patients must be at least 4 weeks out from completion of surgery

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

- Absolute neutrophil count >= 1,000/mcL

- Platelets >= 100,000/mcL

- Total bilirubin =< 1.5 X institutional upper limit of normal

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT])
=< 2.5 X institutional upper limit of normal

- Creatinine =< 1.5 X institutional upper limit of normal

- The effects of entinostat and 5-azacitidine on the developing human fetus at the
recommended therapeutic dose are unknown; for this reason, 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

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients must be within 8 weeks of completing surgery

- Patients who have received prior chemotherapy or radiation for treatment of their
current diagnosis of lung cancer

- Patients with sub-lobar resections (ie: wedge resection or segmentectomy)

- Patients without mediastinal lymph node specimens from mediastinoscopy or surgery (at
least level R4 or 7 for right sided tumors OR at least level 5, 6 or 7 for left sided
tumors)

- Patients may not be receiving any other investigational agents

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to entinostat, 5-azacitidine or other agents used in the study

- 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 because entinostat and 5-azacitidine are
agents with the potential for teratogenic or abortifacient effects; because there is
an unknown but potential risk for adverse events in nursing infants secondary to
treatment of the mother with entinostat or 5-azacitidine, breastfeeding should be
discontinued if the mother is treated on this protocol; these potential risks may also
apply to other agents used in this study

- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
therapy are ineligible because of the potential for pharmacokinetic interactions with
entinostat or 5-azacitidine; in addition, these patients are at increased risk of
lethal infections when treated with marrow-suppressive therapy