RECRUITING

Evaluation of Canakinumab in High-Risk Former-Smokers

Conditions

Cigarette Smoking-Related Carcinoma Lung Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial tests the impact of canakinumab on biologic samples (buccal, nasal, and blood) from former smokers with increased risk of cancer. Canakinumab blocks the activity of a protein called interleukin-1 beta (IL-1b), an agent of the inflammatory system and is used for the treatment of different non-cancer diseases (like auto-inflammatory diseases). Giving canakinumab may block the inflammatory system and could have positive effects to reduce cancer growth.

Official Title

Molecular Studies of Canakinumab in High-Risk Former-Smokers (CANIFS)

Quick Facts

Study Start:2024-03-11

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06038526

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 73 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age 55-73 (age criteria aligns with Canakinumab Antiinflammatory Thrombosis Outcome Study \[CANTOS\] trial) * If female: evidence of post-menopausal status or negative urinary or serum pregnancy test (unknown impact on pregnancy). * Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. * Male sterilization (at least 6 months prior to screening). For female participants on the study, the vasectomized male partner should be the sole partner for that participant * Use of oral, (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \< 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. * Women \>= 50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \> 1 year ago, had chemotherapy-induced menopause with last menses \> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy) * Former smoker with no use in \>= 5 years prior to enrollment (targets former smoker population) * CO =\< 8ppm (targets/confirms former smoker population) * Pack-years history of \>= 30 (defined as high risk) * No unstable or significant medical conditions as determined by medical history (see exclusion criteria below - to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures) * C-reactive protein high-sensitivity (hsCRP) levels \>= 2 mg/L (defined as increased risk) * Negative coronavirus disease (COVID-19) test (if applicable). According to institutional standards, which may evolve throughout the study, if a subject self-reports testing positive for COVID-19, the condition should be resolved without ongoing symptoms for at least three months. If a subject tests positive before the first bronchoscopy, the subject would be placed on a wait list for at least three months and re-tested before his/her appointment; if a subject tests positive before a follow-up bronchoscopy, his/her participation will be withdrawn by the principal investigator (PI) * Able to read adequately to complete the survey and related study documents or give consent	* Smoked tobacco or cannabis within 5 years of enrollment (target study population is former smokers) * Used an electronic cigarette or vaped including tetrahydrocannabinol (THC) within 5 years of enrollment (impacts biomarkers). Smoking or vaping any form of tobacco product or cannabis/THC is an exclusion; however, other use of THC administration (e.g., edible, topical, etc.) are permitted * CO \> 8ppm (target study population is former smokers) * History of or recent exposure to tuberculosis (TB) as documented in the electronic medical record (EMR) and/or testing (impacts risk) * Body mass index (BMI) \> 45 (risk of unstable airway) * Taking acetylsalicylic acid (ASA) or nonsteroidal anti-inflammatory drugs (NSAIDs) daily or most days per week (impacts biomarkers and risk) * Concomitant diseases and life-threatening conditions (e.g., cancer or kidney, liver, immune system disorders) * Prior diagnosis of chronic pulmonary disease (e.g., asthma with regular use of medications, chronic bronchitis, and restrictive lung disease) (impacts biomarkers and risk) * Acute bronchitis or pneumonia within 1 year (impacts biomarkers) * COVID-19 diagnosis or related symptoms within the last 3 months (impacts biomarkers and risk). According to institutional standards, which may evolve throughout the study, if a subject self-reports testing positive for COVID-19, the condition should be resolved without ongoing symptoms for at least three months. If a subject tests positive before the first bronchoscopy, the subject would be placed on a wait list for at least three months and re-tested before his/her appointment; if a subject tests positive before a follow-up bronchoscopy, his/her participation will be withdrawn by the PI * General anesthesia within 1 year (impacts biomarkers) * Regular use of inhalant medications in the last 3 months (impacts biomarkers) * Use of antibiotics in prior 30 days (impacts biomarkers) * Use of steroids, including corticosteroids and inhaled corticosteroids, in prior 30 days (impacts biomarkers) * Use of prohibited concomitant therapy including but not limited to immunosuppressants (impacts biomarkers and risk). Prohibited concomitant therapy: * Immunosuppressants * Use of any treatments below is NOT allowed after the start of study treatment due to potential increase in immunosuppressant related concomitant conditions. They are prohibited for the duration of the study and for at least 130 days after discontinuation of study treatment. If a subject chooses to continue one of the medications below, they will be followed. * Anti-retro-viral and / or biologic drugs targeting the immune system (e.g., TNF blockers, anakinra, rituximab, abatacept, tocilizumab) * Immune modulating agent in doses with systemic effects including but not limited to * Prednisone \> 20 mg (or equivalent) oral or intravenous daily for \> 14 days; * Prednisone \> 5 mg and =\< 20 mg (or equivalent) daily for \> 30 days; * Equivalent dose of methotrexate \> 15 mg weekly. * Cytochrome P450 Substrates - The formation of CYP450 enzymes is suppressed by increased levels of cytokines (e.g., IL-1) during chronic inflammation. Thus, it is expected that for a molecule that binds to IL-1, such as canakinumab, the formation of CYP450 enzymes could be normalized. This is clinically relevant for CYP450 substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g., warfarin). Upon initiation of canakinumab, in patients being treated with these types of medicinal products, therapeutic monitoring of the effect or drug concentration should be performed and the individual dose of the medicinal product may need to be adjusted as needed * Live or attenuated vaccines within 90 days of study treatment and after initiation of study drug (impacts biomarkers and risk). Subjects must be discontinued from the trial if administered any live or attenuated vaccine during the course of the study * Allergies to study medications, such as, lidocaine, versed, fentanyl or cetacaine (impacts risk) * Bronchoscopy or any other lung procedure for any reason within the previous 6 months (impacts biomarkers) * Current or recent (within three months) alcohol or drug abuse problems (impacts risk) * Unable to read for comprehension or completion of study documents (impacts risk)

Inclusion Criteria

Exclusion Criteria

* Age 55-73 (age criteria aligns with Canakinumab Antiinflammatory Thrombosis Outcome Study \[CANTOS\] trial)
* If female: evidence of post-menopausal status or negative urinary or serum pregnancy test (unknown impact on pregnancy).
* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
* Male sterilization (at least 6 months prior to screening). For female participants on the study, the vasectomized male partner should be the sole partner for that participant
* Use of oral, (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \< 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
* Women \>= 50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \> 1 year ago, had chemotherapy-induced menopause with last menses \> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)
* Former smoker with no use in \>= 5 years prior to enrollment (targets former smoker population)
* CO =\< 8ppm (targets/confirms former smoker population)
* Pack-years history of \>= 30 (defined as high risk)
* No unstable or significant medical conditions as determined by medical history (see exclusion criteria below - to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures)
* C-reactive protein high-sensitivity (hsCRP) levels \>= 2 mg/L (defined as increased risk)
* Negative coronavirus disease (COVID-19) test (if applicable). According to institutional standards, which may evolve throughout the study, if a subject self-reports testing positive for COVID-19, the condition should be resolved without ongoing symptoms for at least three months. If a subject tests positive before the first bronchoscopy, the subject would be placed on a wait list for at least three months and re-tested before his/her appointment; if a subject tests positive before a follow-up bronchoscopy, his/her participation will be withdrawn by the principal investigator (PI)
* Able to read adequately to complete the survey and related study documents or give consent

* Smoked tobacco or cannabis within 5 years of enrollment (target study population is former smokers)
* Used an electronic cigarette or vaped including tetrahydrocannabinol (THC) within 5 years of enrollment (impacts biomarkers). Smoking or vaping any form of tobacco product or cannabis/THC is an exclusion; however, other use of THC administration (e.g., edible, topical, etc.) are permitted
* CO \> 8ppm (target study population is former smokers)
* History of or recent exposure to tuberculosis (TB) as documented in the electronic medical record (EMR) and/or testing (impacts risk)
* Body mass index (BMI) \> 45 (risk of unstable airway)
* Taking acetylsalicylic acid (ASA) or nonsteroidal anti-inflammatory drugs (NSAIDs) daily or most days per week (impacts biomarkers and risk)
* Concomitant diseases and life-threatening conditions (e.g., cancer or kidney, liver, immune system disorders)
* Prior diagnosis of chronic pulmonary disease (e.g., asthma with regular use of medications, chronic bronchitis, and restrictive lung disease) (impacts biomarkers and risk)
* Acute bronchitis or pneumonia within 1 year (impacts biomarkers)
* COVID-19 diagnosis or related symptoms within the last 3 months (impacts biomarkers and risk). According to institutional standards, which may evolve throughout the study, if a subject self-reports testing positive for COVID-19, the condition should be resolved without ongoing symptoms for at least three months. If a subject tests positive before the first bronchoscopy, the subject would be placed on a wait list for at least three months and re-tested before his/her appointment; if a subject tests positive before a follow-up bronchoscopy, his/her participation will be withdrawn by the PI
* General anesthesia within 1 year (impacts biomarkers)
* Regular use of inhalant medications in the last 3 months (impacts biomarkers)
* Use of antibiotics in prior 30 days (impacts biomarkers)
* Use of steroids, including corticosteroids and inhaled corticosteroids, in prior 30 days (impacts biomarkers)
* Use of prohibited concomitant therapy including but not limited to immunosuppressants (impacts biomarkers and risk). Prohibited concomitant therapy:
* Immunosuppressants
* Use of any treatments below is NOT allowed after the start of study treatment due to potential increase in immunosuppressant related concomitant conditions. They are prohibited for the duration of the study and for at least 130 days after discontinuation of study treatment. If a subject chooses to continue one of the medications below, they will be followed.
* Anti-retro-viral and / or biologic drugs targeting the immune system (e.g., TNF blockers, anakinra, rituximab, abatacept, tocilizumab)
* Immune modulating agent in doses with systemic effects including but not limited to
* Prednisone \> 20 mg (or equivalent) oral or intravenous daily for \> 14 days;
* Prednisone \> 5 mg and =\< 20 mg (or equivalent) daily for \> 30 days;
* Equivalent dose of methotrexate \> 15 mg weekly.
* Cytochrome P450 Substrates - The formation of CYP450 enzymes is suppressed by increased levels of cytokines (e.g., IL-1) during chronic inflammation. Thus, it is expected that for a molecule that binds to IL-1, such as canakinumab, the formation of CYP450 enzymes could be normalized. This is clinically relevant for CYP450 substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g., warfarin). Upon initiation of canakinumab, in patients being treated with these types of medicinal products, therapeutic monitoring of the effect or drug concentration should be performed and the individual dose of the medicinal product may need to be adjusted as needed
* Live or attenuated vaccines within 90 days of study treatment and after initiation of study drug (impacts biomarkers and risk). Subjects must be discontinued from the trial if administered any live or attenuated vaccine during the course of the study
* Allergies to study medications, such as, lidocaine, versed, fentanyl or cetacaine (impacts risk)
* Bronchoscopy or any other lung procedure for any reason within the previous 6 months (impacts biomarkers)
* Current or recent (within three months) alcohol or drug abuse problems (impacts risk)
* Unable to read for comprehension or completion of study documents (impacts risk)

Contacts and Locations

Study Contact

The Ohio State Comprehensive Cancer Center

CONTACT

800-293-5066

OSUCCCClinicaltrials@osumc.edu

Principal Investigator

Peter G Shields, MD

PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Peter Shields

Peter G Shields, MD, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-11

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-03-11

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Cigarette Smoking-Related Carcinoma
Lung Carcinoma