Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Small Cell Lung Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Small Cell Lung Cancer

Anti-Inflammatory Agents

Respiratory System Agents

All Drugs and Chemicals

Budesonide

Bronchodilator Agents

Anti-Asthmatic Agents

Glucocorticoids

Hormones

Hormone Antagonists

Inhaled Budesonide 800 ug twice daily for 1 year

Inhaled Budesonide 800 micrograms (ug) twice daily for one year.

Inhaled placebo twice daily for one year.

Placebo

Giulia Veronesi, MD

Scott M. Lippman, MD, FACP

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of budesonide may keep lung cancer from forming in patients with lung nodules.

PURPOSE: This randomized phase II trial is studying how well inhalation budesonide works in treating patients with lung nodules who are at high risk of lung cancer.

OBJECTIVES:

Primary

* Evaluate the effect, in terms of size and number reduction of computed tomography (CT) scan-detected undetermined lung nodules, in asymptomatic subjects with lung nodules at high-risk for developing lung cancer treated with inhaled budesonide vs placebo.

Secondary

* Compare average modification of nodule size and nodule number due to inhaled budesonide versus placebo.
* Correlate the modulation of biological markers of lung cancer in serum and sputum after treatment with the modification of lung nodules sizes.
* Determine treatment toxicity, side effects, and safety of inhaled budesonide.
* Evaluate the role of CT scans in estimating the grade of respiratory impairment and emphysema.
* Determine the effect of inhaled budesonide on respiratory function before and after treatment.

OUTLINE: This is a randomized, double-blind, placebo controlled study.

Participants are stratified according to gender, smoking habit (current vs former smoker), and nodule characteristics (solid vs semisolid or non-solid). Participants are randomized into 1 of 2 treatment arms.

* Arm I: Subjects receive inhaled budesonide twice daily for 1 year in the absence of unacceptable toxicity.
* Arm II: Subjects receive inhaled placebo twice daily for 1 year in the absence of unacceptable toxicity.

Participants undergo blood and sputum collection periodically during study for biomarker and correlative studies.

After completion of study therapy, subjects are followed at 1 month and continue CT scan screening.

PROJECTED ACCRUAL: A total of 202 patients will be accrued for this study.

Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer

Randomized Phase II Trial of Budesonide Turbuhaler® 800 Micrograms/Twice Daily Versus Placebo in High-Risk Population With Undetermined Lung Nodules Detected at Screening Low Dose CT Scan

Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection: Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4\&5 mm. Nodules may be stable or grown from the previous year (\< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1\& 8mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be \>1 year; longest diameter \> 8 mm with negative positron positron emission tomography (PET) scan, negative CT enhancement. Nodule should have grown with doubling time between 1\& 5 years; -longest diameter \>8mm, non solid or partially solid nodules, stable or grown with doubling time between 1\&5 years. Participants followed from baseline to 3 Years, follow up CT assessment planned at 12 months.

Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection. Nodule type categorized as: Nonsolid, Partially Solid, or Solid. Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4\&5 mm. Nodules may be stable or grown from the previous year (\< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1\& 8mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be \>1 year; longest diameter \> 8 mm with negative positron positron emission tomography (PET) scan, negative CT enhancement. Nodule should have grown with doubling time between 1\& 5 years; -longest diameter \>8mm, non solid or partially solid nodules, stable or grown with doubling time between 1\&5 years

For single nodules \>5 mm, clinical meaningful shrinkage of 30% or \> longest diameter (LD) considered treatment success after 1 year treatment; for \<5 mm, complete disappearance considered treatment success. Multiple lesions success is complete response (CR) or partial response (PR) according to RECIST while failure when progression disease (PD) or stable disease (SD). CR: disappearance all target \& non target lesions + no appearance new lesions; PR: CR for target lesions+incomplete/SD for non target lesions+no new lesions or PR (i.e., 30%\<sum LD target lesions) for target lesions + no PD for non target lesions + no appearance of new lesions; PD: PD (at least 20% \> sum LD of target lesions) for target lesions irrespective of response of non target lesions or PD for non target lesions irrespective of response for target lesions/or appearance new lesions irrespective of response of target/or non target lesions; SD: neither sufficient shrinkage for PR nor increase for PD.

Number of participants with response according to RECIST criteria. For single nodules \> 5 mm, clinical meaningful shrinkage of 30% or \> of longest diameter (LD) considered treatment success after 1 year of treatment. For single nodules with LD \<5 mm, complete disappearance considered treatment success. In case of multiple lesions success of treatment is when complete response (CR) or partial response (PR) occurs according to RECIST criteria.

National Cancer Institute (NCI)

Arm I: Budesonide

Arm II: Placebo

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Italy

Region of Enrollment

Three (3) participants in Arm I: Budesonide, and one (1) in Arm II: Placebo later refused follow up CT and were excluded from overall analysis.

Powel H. Brown, MD, PhD/Professor of Medicine and Cancer Prevention

Nonsolid

Partially Solid

Solid

Per person analysis in overall randomized study (202 participants) using identification (baseline) CT.

Number CT- Detected Lung Nodules by Participant

4-5 mm

5-8 mm

>8 mm

Per person analysis. Per person analysis in overall randomized study (202 participants) using identification (baseline) CT.

Size of CT- Detected Lung Nodules by Participant

CR/PR

Per person analysis. Excluded from analysis were three participants in Arm I: Budesonide and one participant in Arm II: Placebo who refused the Computed Tomography (CT) scan.

Number of Participant Overall Responses as Measured by RECIST Criteria at 12 Months

Subsolid, CR/PR

Subsolid, SD

Subsolid, PD

Solid, CR/PR

Solid, SD

Solid, PD

Per person analysis. Excluded from analysis were three participants in Arm I: Budesonide and one participant in Arm II: Placebo who refused the follow up Computed Tomography (CT) scan.

Participant Overall Response (by Tumor Type Subsolid or Solid Tumor) as Measured by RECIST Criteria at 12 Months

Inhaled Budesonide 800 micrograms (ug) twice daily for 1 year

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer	NCT00321893	Lung Cancer	Budesonide Placebo	50 Years -	National Cancer Institute (NCI)
Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer	NCT00321893	Lung Cancer	Budesonide Placebo	50 Years -	National Cancer Institute (NCI)

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