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Honokiol for Non-Small Cell Lung Cancer

Phase 1

Waitlist Available

Led By Jun Zhang, MD

Research Sponsored by The Methodist Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate organ and marrow function: Hemoglobin ≥9.0 g/dl, Absolute neutrophil count ≥1000/μL, Platelet count ≥100,000/μL, Serum total bilirubin (TB) ≤1.5 x institutional upper limit of normal, Aspartate transaminase/alanine transaminase ≤5 x institutional ULN, Creatinine ≤1.5X the ULN or measured creatinine clearance ≥ 60 mL/min.

Stage I Non Small Cell Lung Cancer, tumor less than 4 cm.

Must not have

Use of agents that target the mitochondrial metabolism.

Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 2.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening tissue collection to post-intervention tissue collection, an average of 3 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety of a dietary supplement called honokiol for preventing lung cancer. It will include male and female patients over 18 years old with early stage lung cancer who are scheduled for

Who is the study for?

This trial is for men and women over 18 with early-stage Non-Small Cell Lung Cancer scheduled for curative surgery. Only patients with stage I lung cancers smaller than 4 cm are eligible, due to recent treatments approved for larger tumors.

What is being tested?

The study tests the safety of honokiol, a dietary supplement, as a preventive treatment for lung cancer. About 15 participants will take honokiol for two weeks before their surgery to find the highest dose they can tolerate without severe side effects.

What are the potential side effects?

Since this is a Phase I trial primarily focused on determining the Maximum Tolerated Dose (MTD) of honokiol, specific side effects are not listed but may include typical reactions to new supplements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood counts and liver/kidney functions are within normal ranges.

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My lung cancer is in an early stage and the tumor is small.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not using drugs that affect how my cells' powerhouses work.

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My daily activity is limited due to my health condition.

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I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks and have recovered from any side effects.

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I am currently on medication for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening tissue collection to post-intervention tissue collection, an average of 3 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening tissue collection to post-intervention tissue collection, an average of 3 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening tissue collection to post-intervention tissue collection, an average of 3 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose of Honokiol therapy

Secondary study objectives

Dose Limiting Toxicities of Honokiol therapy

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Number of participants with tumor necrosis

+1 more

Other study objectives

Tissue immune correlative biomarkers of honokiol therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: HonokiolExperimental Treatment1 Intervention

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 and this will be determined using Bayesian Optimal Interval Design (BOIN)

0 / 6Eligibility criteria met