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The primary objective of this pilot study is to determine if AER101 can decrease glycolysis in non-small cell lung cancer (NSCLC). Glycolysis is the process cells use to break down sugar (glucose) into a smaller substance in the fluid part inside the cell. Many lung cancers begin in bronchi, bronchioles and alveoli cells surrounding the airways, which enables nebulization to deposit AER101 on lung tumors.
Participants in the study will self-administer AER101 via a hand-held personal nebulizer three times per day (dosing at least 4 hours apart) for 14 days prior to undergoing surgery for lung cancer.
This is a pilot study that will enroll 5 patients with Stage I or Stage II NSCLC. Each patient will receive a nebulizer and will self-administer the study drug 3 times a day for 14 days. The research team will perform a PET CT scan at the beginning of the study (no more than 30 days prior to study) and again at the last treatment. The final treatment will be done at the clinic so that the PET/CT can be performed within about one hour. Patient surgery will already be scheduled to occur shortly after the treatment has been completed.
Patients will also complete a daily assessment survey at each treatment time.
There is only one treatment arm and no control group.
The study is of minimal risk and the investigator expects enrollment to be completed in approximately 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebulized AER 101 | Experimental | Nebulized AER101, self-administered 3 times per day at 5 mL per treatment for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AER101 | Drug | Nebulization of AER101 |
|
| Measure | Description | Time Frame |
|---|---|---|
| PET SUVmax | decreased glycolysis | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| NSCLC System Assessment Questionnaire | Patients are asked to rate coughing episodes, chest pain, shortness of breath, fatigue, and appetite. The PRO Consortium's 9 NSCLC Working Group developed the NSCLC-SAQ with consideration of the recommendations and scientific best practices set forth in the FDA guidance. The NSCLC patient symptoms are each rated from 1 (Never/no pain/No Coughing) to 5 (Always/Very Severe). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Theresa J Lander | Contact | 405-271-8001 | 39509 | theresa-lander@ou.edu |
| Matthew R Reinersman, MD | Contact | 405-271-4505 | matthew-reinersman@ou.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Reinersman, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OU Medical Center Hospital | Oklahoma City | Oklahoma | 73106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34567289 | Result | Bushnell DM, Atkinson TM, McCarrier KP, Liepa AM, DeBusk KP, Coons SJ; Patient-Reported Outcome Consortium's NSCLC Working Group. Non-Small Cell Lung Cancer Symptom Assessment Questionnaire: Psychometric Performance and Regulatory Qualification of a Novel Patient-Reported Symptom Measure. Curr Ther Res Clin Exp. 2021 Aug 26;95:100642. doi: 10.1016/j.curtheres.2021.100642. eCollection 2021. |
| Label | URL |
|---|---|
| FDA instructions for when an IND is required | View source |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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Proof-of-concept, single treatment group, participants blinded to formulation.
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Patients are blinded to the specific formulation of AER101.
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| Once daily during 14 day intervention |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73106 | United States |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |