Beta-Glucan for Melanoma

Recruiting in Palo Alto (17 mi)

Overseen by Kelly M McMasters, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Kelly McMasters

Must be taking: Pembrolizumab

Must not be taking: Immunosuppressive therapy

Disqualifiers: Autoimmune diseases, Active infection, others

No Placebo Group

Breakthrough Therapy

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing whether taking beta-glucan by mouth can help boost the immune system in patients with advanced melanoma who are already receiving Pembrolizumab. The goal is to see if this combination can make the immune system more effective at preventing cancer from coming back. Researchers will look at how well the immune system works and track patient outcomes like cancer recurrence and survival. Recent studies showed promising results about the combination of β-glucans and immune checkpoint inhibitors for patients affected by different solid tumors.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are on ongoing immunosuppressive therapy.

What evidence supports the effectiveness of the treatment Beta-Glucan for melanoma?

Research shows that β-glucan, a natural compound, can help reduce tumor size and improve survival rates in melanoma by boosting the immune system, particularly through the action of natural killer cells. Additionally, β-glucans have been shown to enhance the effects of chemotherapy and reshape immune cells to better fight cancer. ^{1 2 3 4 5}

Is beta-glucan safe for human use?

Beta-glucans are generally considered safe and have been used in various clinical studies for their immune-boosting and other health benefits. Studies in animals, such as rats, have shown no significant toxicity even at high doses, and they have been used safely in humans for conditions like cancer and metabolic disorders. ^{1 3 5 6 7}

How does the beta-glucan treatment for melanoma differ from other treatments?

Beta-glucan is unique because it is a natural compound that boosts the immune system, particularly by activating natural killer (NK) cells, which helps fight melanoma. Unlike traditional chemotherapy, beta-glucan can be taken orally and enhances the effects of other cancer treatments, making it a promising complementary therapy. ^{1 4 5 8 9}

Research Team

Kelly M McMasters, MD

Principal Investigator

University of Louisville

Eligibility Criteria

This trial is for adults with Stage III-IV melanoma who are starting or have been on Pembrolizumab therapy. They should not currently have the disease, be new to treatment or haven't had it in over 6 months, and must be able to swallow pills. People with a history of beta-glucan sensitivity, other cancers, immune suppression therapy, serious illnesses like heart failure or infections, or certain mental health issues can't join.

Inclusion Criteria

I can care for myself but may not be able to do heavy physical work.

I am 18 years old or older.

I can swallow pills.

Exclusion Criteria

I am currently on continuous immunosuppressive medication.

I have been diagnosed with mucosal melanoma.

I do not have any severe illnesses that could interfere with the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Pembrolizumab for 21 days followed by beta-glucan for 21 days

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Beta-Glucan (Dietary Supplement)

Trial Overview The study is testing how Beta-Glucan affects the immune response in patients taking Pembrolizumab for advanced melanoma. It aims to see if this combination improves outcomes compared to what's expected from Pembrolizumab alone.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

All subjects will undergo 21 days of Pembrolizumab followed by 21 days of beta-glucan. Pembrolizumab: 200 mg/100mL IV in three week intervals Beta-glucan: 500mg (1 capsule) by mouth twice a day for 21 days

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Louisville Louisville, KY

Who Is Running the Clinical Trial?

Kelly McMasters

Lead Sponsor

Trials

1

Patients Recruited

30+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucan Supplementation Has Strong Anti-melanoma Effects: Role of NK Cells. Vetvicka, V., Vetvickova, J.[2015]

Certain β-glucans, specifically curdlan, yeast-b, and zymosan, can re-polarize immune-suppressive macrophages into a more active M1-like phenotype, enhancing their ability to produce immune signals and recruit other immune cells.

These β-glucans promote the secretion of chemo-attractants that help in drawing monocytes and neutrophils to the tumor site, potentially improving anti-cancer T-cell responses in the immune-suppressive tumor microenvironment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curdlan, zymosan and a yeast-derived β-glucan reshape tumor-associated macrophages into producers of inflammatory chemo-attractants. de Graaff, P., Berrevoets, C., Rӧsch, C., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

β-Glucan Metabolic and Immunomodulatory Properties and Potential for Clinical Application. Murphy, EJ., Rezoagli, E., Major, I., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

β-Glucans and their applications in cancer therapy: focus on human studies. Aleem, E.[2019]

β-glucans are safe and functional polysaccharides that can enhance the immune response against tumors by activating innate immune cells, making them a promising immunostimulant in cancer treatment.

Clinical studies have shown that soluble β-glucans can effectively bind to immune cell receptors, leading to pro-inflammatory responses that bolster the body's antitumor defenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antitumor effect of soluble β-glucan as an immune stimulant. Wu, L., Zhao, J., Zhang, X., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of beta-glucans on porcine leukocytes. Sonck, E., Stuyven, E., Goddeeris, B., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the toxicity of concentrated barley beta-glucan in a 28-day feeding study in Wistar rats. Delaney, B., Carlson, T., Frazer, S., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barley β-glucan accelerates wound healing by favoring migration versus proliferation of human dermal fibroblasts. Fusté, NP., Guasch, M., Guillen, P., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orally administered beta-glucans enhance anti-tumor effects of monoclonal antibodies. Cheung, NK., Modak, S., Vickers, A., et al.[2020]

References

1. Greece pubmed.ncbi.nlm.nih.gov

Glucan Supplementation Has Strong Anti-melanoma Effects: Role of NK Cells. [2015]

2. Germany pubmed.ncbi.nlm.nih.gov

Curdlan, zymosan and a yeast-derived β-glucan reshape tumor-associated macrophages into producers of inflammatory chemo-attractants. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

β-Glucan Metabolic and Immunomodulatory Properties and Potential for Clinical Application. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

β-Glucans and their applications in cancer therapy: focus on human studies. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Antitumor effect of soluble β-glucan as an immune stimulant. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of beta-glucans on porcine leukocytes. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of the toxicity of concentrated barley beta-glucan in a 28-day feeding study in Wistar rats. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Barley β-glucan accelerates wound healing by favoring migration versus proliferation of human dermal fibroblasts. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Orally administered beta-glucans enhance anti-tumor effects of monoclonal antibodies. [2020]