Honokiol in Early-Stage Resectable Non-Small Cell Lung Cancer
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Registration Number
- NCT06566443
- Lead Sponsor
- The Methodist Hospital Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria:<br><br> 1. The patient provides written informed consent for the trial. Spanish speaking<br> patients will be included and translation services will be provided as needed.<br><br> 2. Male or female, 18 years of age or older, on the day of informed consent signing.<br><br> 3. Stage I Non Small Cell Lung Cancer, tumor less than 4 cm<br><br> 4. Measurable disease according to the Response evaluation criteria in solid tumors<br> (RECIST 1.1) within 30 days of treatment.<br><br> 5. Expected life expectancy of at least 6 months<br><br> 6. Adequate organ and marrow function as defined below:<br><br> Hemoglobin =9.0 g/dl (without blood transfusion within 2 weeks of laboratory test<br> used to determine eligibility) Absolute neutrophil count =1000/µL (without<br> granulocyte colony stimulating factor support within 2 weeks of laboratory test used<br> to determine eligibility) Platelet count =100,000/µL (without transfusion within 2<br> weeks of laboratory test used to determine eligibility)- Serum total bilirubin (TB)<br> =1.5 x institutional upper limit of normal (ULN; In the case of known Gilbert's<br> syndrome, a higher serum TB [>1.5 x ULN] is allowed), Aspartate transaminase/alanine<br> transaminase =5 x institutional ULN Creatinine =1.5X the ULN or measured creatinine<br> clearance = 60 mL/min/1.<br><br> 7. Willing and able to comply with the protocol for the duration of the trial including<br> undergoing treatment and scheduled visits and examinations.<br><br>Exclusion Criteria:<br><br> 1. Currently participating and receiving study therapy or has participated in a study<br> of an investigational agent and received study therapy or used an investigational<br> device within 3 weeks of trial treatment administration.<br><br> 2. Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2<br> weeks prior to trial treatment administration or who has not recovered (i.e., =<br> Grade 1 or at baseline) from Adverse Events (AEs) due to a previously administered<br> agent.<br><br> 3. Use of agents that target the mitochondrial metabolism.<br><br> 4. Has a known additional malignancy that is progressing or requires active treatment.<br> Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of<br> the skin that has undergone potentially curative therapy or in situ cervical cancer.<br><br> 5. The patient has serious and/or uncontrolled preexisting medical condition(s) that,<br> in the judgment of the investigator, would preclude participation in this study (for<br> example, interstitial lung disease, severe dyspnea at rest or requiring oxygen<br> therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min],<br> history of major surgical resection involving the stomach or small bowel, or<br> preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition<br> resulting in baseline Grade 2 or higher diarrhea).<br><br> 6. History or current evidence of any condition, therapy, or laboratory abnormality<br> that might confound the results of the trial, interfere with the patient's<br> participation for the full duration of the trial, or is not in the best interest of<br> the patient to participate, in the opinion of the treating investigator.<br><br> 7. Known psychiatric or substance abuse disorders that would interfere with cooperation<br> with the requirements of the trial.<br><br> 8. Eastern Cooperative Oncology Group (ECOG) performance status of = 2.<br><br> 9. Patients must have recovered from all AEs due to previous therapies to = Grade 1 or<br> baseline. Patients with = Grade 2 neuropathy may be eligible. If patient received<br> major surgery, she must have recovered adequately from the toxicity and/or<br> complications from the intervention prior to starting the trial treatment.<br><br> 10. Active infection requiring systemic therapy.<br><br> 11. Confirmed positive pregnancy test in women of childbearing potential (WOCBP).
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose of Honokiol therapy
- Secondary Outcome Measures
Name Time Method Dose Limiting Toxicities of Honokiol therapy;Recommended Phase 2 Dose of Honokiol therapy;Number of participants with tumor necrosis;Number of participants with treatment-related adverse events as assessed by CTCAE v5.0