Non-small Cell Lung CancerPhase 2NCT00783705
Inositol in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia
A Phase 2 study testing inositol in people with Non-small Cell Lung Cancer and Squamous Lung Dysplasia, run by National Cancer Institute (NCI) at 4 sites in 2 countries.
Trial summary
This randomized phase II trial is studying inositol to see how well it works compared with a placebo in preventing lung cancer in current or former smokers with bronchial dysplasia. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of inositol may prevent lung cancer. Read more about this study
- Who is it for?
- Ages 45 to 79 years
- Conditions the study is for
- Non-small Cell Lung Cancer, Squamous Lung Dysplasia
- What is being tested?
- inositol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Nov 2008to May 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed bronchial dysplasia in ≥ 1 site AND meets one of the following criteria:
- Current or former smoker with ≥ a 30 pack-year smoking history and no history of lung cancer
- Stage 0 or I non-small cell lung cancer (NSCLC) curatively treated by surgery (local ablation or resection), adjuvant chemotherapy, or radiotherapy with a ≥ 30 pack-year smoking history
- At least 6 months since prior surgery, adjuvant chemotherapy, or radiotherapy
- No current evidence of lung cancer by CT scan
- No non-calcified lung nodules ≥ 10 mm diameter on spiral CT scan unless cancer is ruled out by PET/CT scan or by biopsy
Show all 48Show fewer
- ECOG performance status 0-1
- Hemoglobin normal
- Leukocyte count ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 1.5 times ULN
- ALT and AST ≤ 1.5 times ULN
- BUN ≤ 1.5 times ULN
- Chloride ≤ 1.5 times ULN
- Total CO_2 ≤ 1.5 times ULN
- Sodium ≤ 1.5 times ULN
- Calcium ≤ 1.5 times ULN
- Potassium ≤ 1.5 times ULN
- Phosphorus ≤ 1.5 times ULN
- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 30mL/min
- Fasting blood glucose normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No cancer within the past 3 years except stage 0 or I NSCLC, nonmelanomatous skin cancer, localized prostate cancer, carcinoma in situ of the cervix, or superficial bladder cancer that was treated > 6 months ago
- No concurrent uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Severe chronic obstructive pulmonary disease requiring supplemental oxygen
- Uncontrolled hypertension
- Psychiatric illness or social situation that would limit compliance with study requirements
- No schizophrenia or bipolar disorder
- No diabetes
- No requirement for supplemental oxygen (continuous or intermittent)
- SaO_2 ≥ 90% on room air
- No history of allergic reactions attributed to inositol
- No history of allergies to any ingredient in the study agent or placebo
- No other concurrent investigational agents
- At least 7 days since prior anticoagulant use (e.g., coumadin or heparin)
- More than 6 months since prior participation in another chemoprevention clinical trial
- No prior pneumonectomy
- No prior solid organ transplantation
- No concurrent lithium, carbamazepine, or valproate
- No concurrent use of other natural health products containing inositol
Who cannot join
None listed.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Albuquerque Veterans Administration Medical Center
Albuquerque, New Mexico, 87108-5128
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Phase IIb Randomized Comparative Study of the Efficacy and Safety of Myo-inositol Versus Placebo in Smokers With Bronchial Dysplasia
This randomized phase II trial is studying inositol to see how well it works compared with a placebo in preventing lung cancer in current or former smokers with bronchial dysplasia. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of inositol may prevent lung cancer. It is not yet known whether inositol is more effective than a placebo in preventing lung cancer in smokers with bronchial dysplasia.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy of myo-inositol (inositol) 9 grams by mouth twice a day for 6 months versus placebo to revert bronchial dysplasia in current/former smokers with or without curatively treated Stage 0/I non-small cell lung cancer.
SECONDARY OBJECTIVES:
- To further define the mechanism(s) of action of pharmacological doses of myo-inositol as a lung cancer chemopreventive agent by evaluating changes in: the number of dysplastic lesions, Ki-67, caspase-3, peroxisome proliferator-activated receptor (PPAR) gamma, cyclin D1, cyclin E and vascular endothelial growth factor (VEGF) immunostaining in bronchial biopsies; gene expression analysis of ribonucleic acid (RNA) from bronchial brush cells; and changes in inflammatory biomarkers (C-reactive protein [CRP], monocyte chemotactic protein-1 [MCP-1], myeloid progenitor inhibitory factor-1 [MPIF-1] and L-Selectin) levels in bronchoalveolar lavage (BAL) and plasma before and after treatment.
II. To collect additional safety and adverse event profiles of participants enrolled in both intervention arms. III. To establish a biospecimen repository archive for future correlative studies.
OUTLINE: Patients are stratified according to smoking status (current vs former), prior lung cancer (yes vs no), and number of dysplastic lesions at baseline (1 vs > 1). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
ARM II: Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
Patients undergo white light and autofluorescence bronchoscopy with bronchoalveolar lavage, bronchial brushings, and biopsies as well as optical coherence tomography imaging and blood sample collection at baseline and after completion of study treatment. Samples are analyzed for tissue biomarkers (e.g., PPAR gamma, Ki-67, caspase-3, cyclin D1, cyclin E, and VEGF) by immunohistochemistry (IHC); cytokine levels (e.g., CRP, MCP-1, MPIF-1, and L-selectin) by ELISA; and gene expression profiles of RNA by microarray.
After completion of study treatment, patients are followed within 30 days.
- Being tested
- placebo, inositol
- 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.
placeboOther
Also called PLCB
Given orally
inositolDrug
Also called myo-inositol
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I (inositol) | Experimental | Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. Receives: Drug: inositol |
| Arm II (placebo) | Experimental | Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis.
The definitions of responses are:
Complete response: regression of all dysplastic lesion (DL) found at baseline to lesions that were no worse than hyperplasia and no new DL that were mild dysplasia or worse; Partial response: regression of some but not all of the DL with no new lesions that are mild dysplasia or worse; Progressive disease: progression of one or more sites by two or more grades or new DL that were mild dysplasia or worse; Stable disease: no complete response, partial response or progression.
Measured: From baseline up to 6 months
Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis.
The definitions of responses are:
Complete response: the regression of a dysplastic lesion (DL) of any grade to one classified as being hyperplastic/normal; Progressive disease: appearance of lesions that were classified as mild dysplasia or worse; Stable disease: lesions that are not classified as complete response or progressive disease
Measured: From baseline up to 6 months
Secondary outcomes (18)
Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment
The change in the number of bronchial dysplastic lesions is defined as disappearance or appearance of lesions.
Measured: From baseline up to 6 months
Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia
Measured: From baseline up to 6 months
Change in Gene Expression Profiles of RNA in Bronchial Brush Cell Samples as Assessed by Microarray
Measured: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Measured: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Measured: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (CCL-2) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Measured: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (MPO) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Measured: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (CC18) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Measured: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (SFTPD) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Measured: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (Total Glutathione) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Measured: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Measured: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (CRP) in Plasma Samples as Assessed by ELISA
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Measured: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (IL-6) in Plasma Samples as Assessed by ELISA
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Measured: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Measured: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (MPO) in Plasma Samples as Assessed by ELISA
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Measured: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (Nitrotyrosine) in Plasma Samples as Assessed by ELISA
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Measured: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Measured: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Measured: From baseline up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Paul Limburg, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783705
- Sponsor's protocol ID
- NCI-2009-00839
- Other IDs
- NCI-2009-00839, CDR0000617846, MAY06-8-01, MAY06-8-01, P30CA015083
- Status last verified
- Oct 2017
- First submitted
- 31 Oct 2008
- Last updated
- 5 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIb Randomized Comparative Study of the Efficacy and Safety of Myo-inositol Versus Placebo in Smokers With Bronchial Dysplasia
- ClinicalTrials.gov ID
- NCT00783705
- Acronym / sponsor ID
- NCI-2009-00839
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Nov 2008
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 3 Nov 2008 (estimated)
- Results
- Posted 25 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial is studying inositol to see how well it works compared with a placebo in preventing lung cancer in current or former smokers with bronchial dysplasia. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of inositol may prevent lung cancer. It is not yet known whether inositol is more effective than a placebo in preventing lung cancer in smokers with bronchial dysplasia.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy of myo-inositol (inositol) 9 grams by mouth twice a day for 6 months versus placebo to revert bronchial dysplasia in current/former smokers with or without curatively treated Stage 0/I non-small cell lung cancer.
SECONDARY OBJECTIVES:
- To further define the mechanism(s) of action of pharmacological doses of myo-inositol as a lung cancer chemopreventive agent by evaluating changes in: the number of dysplastic lesions, Ki-67, caspase-3, peroxisome proliferator-activated receptor (PPAR) gamma, cyclin D1, cyclin E and vascular endothelial growth factor (VEGF) immunostaining in bronchial biopsies; gene expression analysis of ribonucleic acid (RNA) from bronchial brush cells; and changes in inflammatory biomarkers (C-reactive protein [CRP], monocyte chemotactic protein-1 [MCP-1], myeloid progenitor inhibitory factor-1 [MPIF-1] and L-Selectin) levels in bronchoalveolar lavage (BAL) and plasma before and after treatment.
II. To collect additional safety and adverse event profiles of participants enrolled in both intervention arms. III. To establish a biospecimen repository archive for future correlative studies.
OUTLINE: Patients are stratified according to smoking status (current vs former), prior lung cancer (yes vs no), and number of dysplastic lesions at baseline (1 vs > 1). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
ARM II: Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
Patients undergo white light and autofluorescence bronchoscopy with bronchoalveolar lavage, bronchial brushings, and biopsies as well as optical coherence tomography imaging and blood sample collection at baseline and after completion of study treatment. Samples are analyzed for tissue biomarkers (e.g., PPAR gamma, Ki-67, caspase-3, cyclin D1, cyclin E, and VEGF) by immunohistochemistry (IHC); cytokine levels (e.g., CRP, MCP-1, MPIF-1, and L-selectin) by ELISA; and gene expression profiles of RNA by microarray.
After completion of study treatment, patients are followed within 30 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (inositol) | Experimental | Drug: inositolPatients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. |
| Arm II (placebo) | Experimental | Other: placeboPatients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. |
Who may qualify
- Ages
- 45 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (48 listed)
- Histologically confirmed bronchial dysplasia in ≥ 1 site AND meets one of the following criteria:
- No current evidence of lung cancer by CT scan
- ECOG performance status 0-1
- Hemoglobin normal
- Leukocyte count ≥ 3,000/mm³
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboAlso: PLCBGiven orally | Other | Arm II (placebo) |
| inositolAlso: myo-inositolGiven orally | Drug | Arm I (inositol) |
Primary outcome
Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis.
Time frame: From baseline up to 6 months
The definitions of responses are: Complete response: regression of all dysplastic lesion (DL) found at baseline to lesions that were no worse than hyperplasia and no new DL that were mild dysplasia or worse; Partial response: regression of some but not all of the DL with no new lesions that are mild dysplasia or worse; Progressive disease: progression of one or more sites by two or more grades or new DL that were mild dysplasia or worse; Stable disease: no complete response, partial response or progression.
Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis.
Time frame: From baseline up to 6 months
The definitions of responses are: Complete response: the regression of a dysplastic lesion (DL) of any grade to one classified as being hyperplastic/normal; Progressive disease: appearance of lesions that were classified as mild dysplasia or worse; Stable disease: lesions that are not classified as complete response or progressive disease
18 secondary outcomes
Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment
Time frame: From baseline up to 6 months
Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia
Time frame: From baseline up to 6 months
Change in Gene Expression Profiles of RNA in Bronchial Brush Cell Samples as Assessed by Microarray
Time frame: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
Time frame: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
Time frame: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (CCL-2) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
Time frame: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (MPO) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
Time frame: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (CC18) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
Time frame: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (SFTPD) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
Time frame: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (Total Glutathione) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
Time frame: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA
Time frame: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (CRP) in Plasma Samples as Assessed by ELISA
Time frame: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (IL-6) in Plasma Samples as Assessed by ELISA
Time frame: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA
Time frame: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (MPO) in Plasma Samples as Assessed by ELISA
Time frame: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (Nitrotyrosine) in Plasma Samples as Assessed by ELISA
Time frame: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA
Time frame: From baseline up to 6 months
Change in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA
Time frame: From baseline up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Limburg principal investigator
Mayo Clinic
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing inositol in people with Non-small Cell Lung Cancer and Squamous Lung Dysplasia, run by National Cancer Institute (NCI) at 4 sites in 2 countries.
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 48 inclusion and 0 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 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis. (time frame: From baseline up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2017.