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Azacitidine in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer

NCT02009436 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-02-07

No results posted yet for this study

Summary

This pilot phase I trial studies the side effects and best dose of azacitidine in treating patients with lung cancer that is stage IV or has returned after previous treatments (recurrent). Azacitidine is a drug used in chemotherapy that may stop tumor cells from growing or spreading by activating genes that help prevent cancer growth, called tumor suppressor genes. As people age, these genes are silenced by a chemical reaction that occurs naturally in the body, or by exposure to environmental factors such as smoking. Azacitidine may help reverse this process and restore the function of the tumor suppressor genes. Delivering azacitidine directly into the lungs by inhalation may work better in treating lung cancer.

Conditions

  • Recurrent Non-Small Cell Lung Carcinoma
  • Stage IV Non-Small Cell Lung Cancer

Interventions

DRUG

Azacitidine

Given via nebulizer

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Roman Perez-Soler · Albert Einstein College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-09
Primary Completion
2018-07-18
Completion
2018-07-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02009436 on ClinicalTrials.gov