Honokiol for Non-Small Cell Lung Cancer

Overseen By Jun Zhang, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: The Methodist Hospital Research Institute

Must not be taking: Mitochondrial metabolism agents

Disqualifiers: Other malignancy, Uncontrolled conditions, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you have had chemotherapy, targeted therapy, or radiation therapy within 2 weeks before starting the trial. It's best to discuss your specific medications with the trial team.

What makes honokiol unique as a drug for non-small cell lung cancer?

Honokiol is unique because it is a natural compound derived from the Magnolia plant that targets multiple pathways involved in cancer growth, such as inhibiting blood vessel formation (angiogenesis) and affecting cell survival and death processes. It can be used alone or in combination with other chemotherapy drugs like cisplatin to enhance its effectiveness against lung cancer. ^{1 2 3 4 5}

Research Team

Jun Zhang

Principal Investigator

Houston Methodist Neal Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

My cancer can be measured by scans as per specific criteria.

I have given my written consent to participate in the trial.

I am 18 years old or older.

Exclusion Criteria

The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.

History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.

Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take the study drug, honokiol, for 2 weeks prior to surgery to evaluate safety and determine the Maximum Tolerated Dose (MTD)

2 weeks

1 visit (in-person) for treatment initiation

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and dose-limiting toxicities

3 weeks

1 visit (in-person) for follow-up assessment

Long-term Follow-up

Participants are monitored for long-term safety and effectiveness, including tumor necrosis and immune biomarkers

up to 2 years

Treatment Details

Interventions

• Honokiol

Trial Overview 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.

Participant Groups

Group I: Honokiol Experimental Treatment 1 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)

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Findings from Research

Honokiol, a natural compound from Magnolia, has shown promising anti-cancer effects in laboratory and animal studies by targeting key signaling pathways involved in cancer progression, such as NF-κB and STAT3.

Its favorable pharmacokinetic profile after intravenous administration suggests that honokiol could be a viable candidate for clinical trials, paving the way for potential human applications in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Honokiol: a novel natural agent for cancer prevention and therapy. Arora, S., Singh, S., Piazza, GA., et al.[2021]

Liposomal honokiol demonstrated significant antitumor activity against human lung cancer in a study using A549 lung cancer-bearing mice, effectively suppressing tumor growth.

The combination of liposomal honokiol with cisplatin (DDP) not only enhanced tumor growth inhibition but also increased the lifespan of the mice, likely due to increased apoptosis and reduced blood vessel formation in the tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved therapeutic effectiveness by combining liposomal honokiol with cisplatin in lung cancer model. Jiang, QQ., Fan, LY., Yang, GL., et al.[2021]

Honokiol, a natural compound from Magnolia plants, has shown promising anti-cancer effects in various studies, demonstrating its ability to inhibit cancer cell growth and transformation without significant toxicity.

The compound works through multiple mechanisms, targeting key signaling pathways and molecules involved in cancer progression, suggesting its potential for use in clinical trials for treating different types of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Honokiol, an Active Compound of Magnolia Plant, Inhibits Growth, and Progression of Cancers of Different Organs. Prasad, R., Katiyar, SK.[2017]

Honokiol effectively inhibits the growth of human ovarian tumors by inducing apoptosis and altering key proteins involved in cell survival, as demonstrated through various assays in vitro.

In animal models, honokiol not only reduced tumor volume but also decreased microvessel density, indicating its potential to inhibit angiogenesis, making it a promising candidate for ovarian cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Honokiol, a natural therapeutic candidate, induces apoptosis and inhibits angiogenesis of ovarian tumor cells. Li, Z., Liu, Y., Zhao, X., et al.[2012]

Honokiol, a natural compound from Magnolia, has demonstrated significant anti-lung-cancer effects by targeting multiple biological pathways, including inhibiting blood vessel formation (angiogenesis) and regulating cell death processes (apoptosis).

The research suggests that honokiol can be effectively combined with other chemotherapy drugs, potentially enhancing its therapeutic application in lung cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of honokiol in lung cancer therapy: a mini review of its pharmacological mechanism. Wang, J., Mu, HJ., Sun, YL., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Honokiol: a novel natural agent for cancer prevention and therapy. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Improved therapeutic effectiveness by combining liposomal honokiol with cisplatin in lung cancer model. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Honokiol, an Active Compound of Magnolia Plant, Inhibits Growth, and Progression of Cancers of Different Organs. [2017]

4. Ireland pubmed.ncbi.nlm.nih.gov

Honokiol, a natural therapeutic candidate, induces apoptosis and inhibits angiogenesis of ovarian tumor cells. [2012]

5. England pubmed.ncbi.nlm.nih.gov

Use of honokiol in lung cancer therapy: a mini review of its pharmacological mechanism. [2023]