Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Budesonide; Placebo
Intervention description: Inhaled Budesonide 800 micrograms (ug) twice daily for one year.; Inhaled placebo twice daily for one year.
Intervention MeSH terms: Budesonide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 225.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Small cell lung cancer; Non-small cell lung cancer; Budesonide; Entocort EC; Pulmicort Respules; Rhinocort aqua; Aerosol budesonide treatment; Smoking

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Current smokers or former smokers that have stopped within the last 15 years

          2. Smoking history > 20 pack/years

          3. Age > 50 years

          4. Persistent lung nodules detected at Low dose computed tomography (LDCT) scan from
             previous year with 1 of the 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 & 8 mm. Nodules may be stable or
             grown from the previous year. If grown, doubling time should be >1 year; longest
             diameter > 8 mm with negative PET scan, negative CT enhancement. Nodule should have
             grown with a 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

          5. Eastern Cooperative Oncology Group (ECOG) performance status < 1 (Karnofsky >60%)

          6. Participants must have normal organ and marrow function as defined below: Leukocytes
             >3,000/mL, absolute neutrophil count greater than 1,500/mL, platelets greater than
             100,000/mL, total bilirubin lower than 1.5 * upper normal institutional limits,
             aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) lower
             than 1.5 * upper normal institutional limits, creatinine lower than 1.5 * upper normal
             institutional limits

          7. Females must be postmenopausal (ie, at least 1 year passed after the last
             menstruation), surgically sterile, or using acceptable contraceptive measures as
             judged by the Investigator. (A fertile woman is defined as being of child-bearing
             potential, from first menstruation to 1 year after last menstruation.). Negative serum
             beta-HCG for women of childbearing potential will be required at baseline. Should a
             woman become pregnant or suspect she is pregnant while participating in this study,
             she should inform her study physician immediately

          8. Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          1. More than 6 lung nodules (suspect of chronic granulomatous disease)

          2. Lung nodules with clearly benign morphological features at CT scan (i.e, homogenous
             calcification, solid nodules with regular and round or polygonal margins and distance
             from the pleura <1cm)

          3. Subjects currently suffering from malignant disease or having had malignant disease
             within the last 5 years except for cervical carcinoma in situ and non melanoma skin
             cancer

          4. Regular/chronic use of oral or inhaled corticosteroids; regular use being defined as a
             total of 3 months cumulative use in the last 12 months

          5. Use of any other investigational agents at time of enrollment in the study during the
             three months preceding study enrollment

          6. History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to corticosteroid

          7. 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. Any other factor that at the investigator's discretion
             contraindicates the use of inhaled corticosteroids

          8. Pregnant or lactating females, or females planning to become pregnant during the
             study. Should a woman become pregnant or suspect she is pregnant while participating
             in this study, she should inform her study physician immediately. If needed, a
             pregnancy test will be performed on serum during baseline lab test

          9. HIV-positive or other patients with immunodeficiencies should be excluded because of
             the risk of infections