AzTrials
AzTrials

Recurrent Non-Small Cell Lung CarcinomaPhase 1NCT02009436

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

A Phase 1 study testing Azacitidine, Laboratory Biomarker Analysis and Pharmacological Study in people with Recurrent Non-Small Cell Lung Carcinoma and Stage IV Non-Small Cell Lung Cancer, run by Albert Einstein College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Azacitidine, Laboratory Biomarker Analysis and Pharmacological Study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
9 Feb 2015to 18 Jul 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically proven (either histologic or cytologic) diagnosis of stage IV or recurrent non-small cell lung cancer (according to American Joint Committee on Cancer [AJCC] staging, 7th edition)
  • Patient has received at least one prior standard chemotherapy or targeted therapy for treatment of lung cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Absolute neutrophil count (ANC) >= 1,500 cells/ul
  • Platelets >= 100,000 cells/ul
  • Hemoglobin >= 9.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= g/dl is acceptable)
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  • Serum creatinine =< 1.5 x upper limit of normal (ULN)
  • Total bilirubin < 2.0 times the institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x the ULN
  • Adequate pulmonary reserve defined as adequate airflow defined by a measured forced expiratory volume (FEV1) not less than 50% of the predicted value and adequate pulmonary reserve as evidenced by a FEV1/forced vital capacity (FVC) ratio of 65% or greater
  • Patient must sign study specific informed consent prior to study entry
  • Women of childbearing potential must have:
  • A negative serum or urine pregnancy test (sensitivity =< 25 IU human chorionic gonadotropin [HCG]/L) within 72 hours prior to the start of study drug administration
  • Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy

Who cannot join

  • Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study
  • Contraindication to or unwillingness to undergo study related procedures including a repeat bronchoscopy
  • Participation in an investigational drug or device study or treatment with any antineoplastic agent within 14 days of the first day of dosing on this study
  • History of significant bleeding disorder unrelated to cancer, including:
  • Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
  • Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
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  • History of hypersensitivity to mannitol
  • Unwillingness or inability to comply with the study protocol for any other reason
  • Women who:
  • Are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or
  • Have a positive pregnancy test at baseline, or
  • Are pregnant or breastfeeding
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

Other trials in United States

About this study

Official title: Phase I Study of Inhaled Vidaza® in Patients With Advanced NSCLC

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the maximum tolerated dose (MTD) and toxicity of inhaled Vidaza® (azacitidine) with special emphasis on pulmonary toxicity.

SECONDARY OBJECTIVES:

  1. To evaluate the pharmacokinetics of inhaled Vidaza®. II. To determine the changes in global methylation patterns in the bronchial epithelium (bronchial tissue samples) pre and post treatment.

III. To determine the changes in methylation patterns in the exhaled breath. IV. To evaluate the efficacy of inhaled Vidaza® on intra-thoracic tumors (response rate by Response Evaluation Criteria in Solid Tumors [RECIST] criteria for intrapulmonary lesions).

  1. To estimate the progression free, intra-thoracic tumor progression free and overall survival.

VI. To determine the minimum effective dose of inhaled Vidaza® required to induce changes in the methylation status and re-expression of a panel of genes, including 5 candidate tumor suppressor genes (cyclin-dependent kinase inhibitor 2A [p16], h-cadherin [H-Cad], opioid binding protein/cell adhesion molecule-like [OPCML], secreted frizzled-related protein 1 [SFRP-1], and ras association domain family 1 [RASSF1A]) that are silenced in 20-50% of bronchial tissue of heavy smokers with lung cancer.

OUTLINE: This is a dose-escalation study.

Patients receive azacitidine via nebulizer over 20 minutes once daily (QD) on days 1-5 and 15-19. Treatment repeats every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients may continue treatment on a case-by-case basis at the discretion of principal investigator and Institutional Review Board.

After completion of study treatment, patients are followed up at 4-6 weeks and then every 3 months thereafter.

Being tested
Azacitidine, Laboratory Biomarker Analysis, Pharmacological Study
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AzacitidineDrug

    Also called 5 AZC, 5-AC, 5-Azacytidine, 5-AZC

    Given via nebulizer

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Pharmacological StudyOther

    Correlative studies

Study groups in NCT02009436
Study groupRoleWhat they receive
Treatment (azacitidine)ExperimentalPatients receive azacitidine via nebulizer over 20 minutes QD on days 1-5 and 15-19. Treatment repeats every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients may continue treatment on a case-by-case basis at the discretion of principal investigator and Institutional Review Board.
Receives: Drug: Azacitidine; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Minimum effective dose of inhaled azacitidine, defined as the dose required to induce the re-expression of any of the relevant 5 candidate tumor suppressor genes by two fold between pre and post treatment bronchial biopsies in 50% of evaluable patients

    The data will be analyzed and presented in descriptive fashion.

    Measured: Up to day 28 after the first course of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2013 (estimated)
  2. Study start9 Feb 2015
  3. Primary completion18 Jul 2018
  4. Study completion18 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02009436
Sponsor's protocol ID
2013-382
Other IDs
NCI-2014-01269, 2013-382, P30CA013330
Status last verified
Feb 2020
First submitted
21 Oct 2013
Last updated
7 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Cheng H, Zou Y, Shah CD, Fan N, Bhagat TD, Gucalp R, Kim M, Verma A, Piperdi B, Spivack SD, Halmos B, Perez-Soler R. First-in-human study of inhaled Azacitidine in patients with advanced non-small cell lung cancer. Lung Cancer. 2021 Apr;154:99-104. doi: 10.1016/j.lungcan.2021.02.015. Epub 2021 Feb 17.

    PubMed 33636454

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Azacitidine, Laboratory Biomarker Analysis and Pharmacological Study in people with Recurrent Non-Small Cell Lung Carcinoma and Stage IV Non-Small Cell Lung Cancer, run by Albert Einstein College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minimum effective dose of inhaled azacitidine, defined as the dose required to induce the re-expression of any of the relevant 5 candidate tumor suppressor genes by two fold between pre and post treatment bronchial biopsies in 50% of evaluable patients (time frame: Up to day 28 after the first course of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02009436, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.

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