This is a Phase I Trial evaluating the safety of the dietary supplement honokiol for lung cancer chemoprevention. Female or male patients aged 18 years, or older, with early stage lung cancer who have been scheduled for curative surgery will be eligible for participation in the study. The study will only enroll patients with stage I lung cancers less than 4 cm, given the recent approval of neoadjuvant chemotherapy and nivolumab for stage IB tumors \> 4 cm. Approximately, 15 patients will be enrolled in the study. They will take the study drug, honokiol, for 2 weeks prior to the surgery. The primary endpoint will be the Maximum Tolerated Dose (MTD) of honokiol.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
15
Honokiol will be given orally at a starting dose of 1 capsule (250 mg/ capsule) per day for 2 weeks. Dose levels will escalate based on dose-limiting toxicity occurrence. We will start at one capsule (250 mg) once daily, dose 0 would be one capsule (250 mg) twice daily, dose +1 would be 500mg in the AM and 250mg in the evening, and +2 would be 500 mg twice daily.
Houston Methodist Neal Cancer Center
Houston, Texas, United States
RECRUITINGMaximum Tolerated Dose of Honokiol therapy
To determine the maximum tolerated dose (MTD) of honokiol therapy in patients with stage I NSCLC, less than 4 cm, who will undergo surgical resection. Review the safety data to determine the dose level at which the maximum tolerable level of toxicity is observed and select as the MTD the dose for which the isotonic estimate of the DLT rate is closest to the target DLT rate.
Time frame: From treatment initiation of each patient, assessed up to 21 days after treatment initiation of final patient, up to 2 years after first enrollment.
Dose Limiting Toxicities of Honokiol therapy
To determine the dose-limiting toxicity (DLT) and other toxicities associated with honokiol therapy, as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0;
Time frame: DLT period will start with initial treatment dose until 21 days after.
Recommended Phase 2 Dose of Honokiol therapy
To determine the recommended Phase II dose (RP2D) of honokiol; Bayesian Optimal Interval (BOIN) design will be used for dose finding.
Time frame: From initial treatment dose until 21 days after.
Number of participants with tumor necrosis
To assess for any evidence of tumor necrosis.
Time frame: From screening tissue collection to post-intervention tissue collection, an average of 3 months.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
To determine the safety and tolerability of honokiol therapy prior to surgery as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Time frame: The safety period will start at baseline and will be assessed through study completion, up to 2 months
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