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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of honokiol, a dietary supplement, for individuals with early-stage non-small cell lung cancer (NSCLC). Researchers aim to determine the safe dosage of honokiol before surgery to remove the cancer. Ideal participants have NSCLC tumors smaller than 4 cm and are scheduled for surgery. The study spans two weeks, during which participants will take honokiol daily before their surgery. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that honokiol is likely to be safe for humans?

Research shows that honokiol, a substance from magnolia tree bark, might help fight lung cancer. Some studies suggest it can slow cancer cell growth and even cause cancer cells to die. However, little is known about its safety for people with lung cancer.

This trial is in its early stages and focuses on how well people can tolerate honokiol. The main goal is to find the highest dose people can take without serious side effects. As a Phase 1 trial, it primarily tests safety rather than effectiveness. Participants will take honokiol for a short time before their surgery, allowing researchers to monitor for any negative effects.

While honokiol looks promising in lab studies, this trial will provide important information about its safety in humans. If honokiol is already approved for other uses, it might suggest safety. However, no information about such approval is available from the sources provided. Therefore, this trial is crucial to understanding honokiol's safety for people with early-stage lung cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Unlike standard treatments for non-small cell lung cancer, which often involve chemotherapy, radiation, or targeted therapies, honokiol is derived from magnolia bark and is being explored for its potential anti-cancer properties. Researchers are excited about honokiol because it works by targeting multiple pathways involved in cancer cell growth and survival, which might offer a new way to fight the disease. Additionally, honokiol's natural origin and unique mechanism of action could lead to fewer side effects compared to conventional treatments, making it a promising option for patients.

What evidence suggests that honokiol might be an effective treatment for non-small cell lung cancer?

Studies have shown that honokiol may help treat non-small cell lung cancer (NSCLC). Research suggests that honokiol can prevent cancer cells from spreading. In lab tests, honokiol slowed the growth of lung cancer tumors in research mice. Another study found that honokiol blocked certain immune cells that aid cancer growth. These findings suggest that honokiol might be a promising option for treating NSCLC by slowing or stopping the cancer. Participants in this trial will receive honokiol to further evaluate its potential benefits in treating NSCLC. ^{1 4 5 6 7}

Who Is on the Research Team?

Jun Zhang

Principal Investigator

Houston Methodist Neal Cancer Center

Are You a Good Fit for This Trial?

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.

Expected life expectancy of at least 6 months.

Exclusion Criteria

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.

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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, 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2543046/

Improved therapeutic effectiveness by combining liposomal ... The combination of liposomal honokiol therapy with DDP also resulted in a significant increase in life span (Figure 1B). Similar results were also found in LLC ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0944711324007505

Liposomal honokiol inhibits non-small cell lung cancer ... This study validated the anti-tumor efficacy of Lipo-HNK against NSCLC. Lipo-HNK reduced the infiltration of MDSCs and M2 macrophages by inhibiting the PI3K/Akt ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0060749

Honokiol Inhibits Non-Small Cell Lung Cancer Cell Migration ... These results indicate that honokiol inhibits non-small cell lung ... These data further suggests that honokiol inhibited the migratory efficiency of NSCLC cells.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06566443

Honokiol in Early-Stage Resectable Non-Small Cell Lung ... 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, ...

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/1471-2407-8-242

Improved therapeutic effectiveness by combining liposomal ... In summary, our data suggest that honokiol alone had the antitumor activity against human lung cancer in A549 lung cancer xenograft model, and ...

6. careacross.com careacross.com/clinical-trials/trial/NCT06566443

Honokiol in Early-Stage Resectable Non-Small Cell Lung ... Summary: 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5295387/

Honokiol suppresses lung tumorigenesis by targeting ... Inhibition of class I histone deacetylases in non-small cell lung cancer by honokiol leads to suppression of cancer cell growth and induction of cell death in ...