CLINICAL TRIAL

Beta-Glucan for Melanoma

Recruiting · 18+ · All Sexes · Louisville, KY

This study is evaluating whether a specific type of fiber may help improve the immune system in individuals with melanoma.

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About the trial for Melanoma

Eligible Conditions
Melanoma Stage III · Melanoma · Melanoma Stage IV

Treatment Groups

This trial involves 2 different treatments. Beta-Glucan is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Beta-Glucan
DIETARYSUPPLEMENT
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Beta-Glucan
2018
N/A
~60

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Members of all racial and ethnic groups are eligible for this study
Must be treatment naïve or have had treatment no less than 6 months prior to enrollment
18 years or older
Must be able to take pills
ECOG performance status of 0-3
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Beta-Glucan will improve 6 primary outcomes in patients with Melanoma. Measurement will happen over the course of Blood for analysis will be drawn at baseline (Day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan treatment..

Changes in percent of lymphocyte cell surface expression markers
BLOOD FOR ANALYSIS WILL BE DRAWN AT BASELINE (DAY 0), 3 WEEKS POST PEMBROLIZUMAB TREATMENT, AND 3 WEEKS POST PEMBROLIZUMAB PLUS ORAL BETA-GLUCAN TREATMENT.
The investigators will quantify percent of lymphocyte cell surface e (i.e., CD45, CD3, CD11b, etc.) from each sample collected by mass cytometry *CyTOF) or flow cytometry
Changes in absolute number of lymphocyte cell surface expression markers
BLOOD FOR ANALYSIS WILL BE DRAWN AT BASELINE (DAY 0), 3 WEEKS POST PEMBROLIZUMAB TREATMENT, AND 3 WEEKS POST PEMBROLIZUMAB PLUS ORAL BETA-GLUCAN
The investigators will quantify absolute number of lymphocyte cell surface (i.e., CD45, CD3, CD11b, etc.) from each sample collected by mass cytometry (CyTOF) or flow cytometry
Changes in percent of intracellular cytokine expression markers
BLOOD FOR ANALYSIS WILL BE DRAWN AT BASELINE (DAY 0), 3 WEEKS POST PEMBROLIZUMAB TREATMENT, AND 3 WEEKS POST PEMBROLIZUMAB PLUS ORAL BETA-GLUCAN
The investigators will quantify percent of intracellular cytokine expression (TNFa, IFNg, etc.) from each sample collected by mass cytometry (CyTOF) or flow cytometry
Changes in fluorescent intensity of intracellular cytokine expression markers
BLOOD FOR ANALYSIS WILL BE DRAWN AT BASELINE (DAY 0), 3 WEEKS POST PEMBROLIZUMAB TREATMENT, AND 3 WEEKS POST PEMBROLIZUMAB PLUS ORAL BETA-GLUCAN
The investigators will quantify fluorescent intensity of intracellular cytokine expression (TNF-a, IFNg, etc.) from each sample collected by mass cytometry (CyTOF) or flow cytometry
Changes in absolute number of intracellular cytokine expression markers
BLOOD FOR ANALYSIS WILL BE DRAWN AT BASELINE (DAY 0), 3 WEEKS POST PEMBROLIZUMAB TREATMENT, AND 3 WEEKS POST PEMBROLIZUMAB PLUS ORAL BETA-GLUCAN
The investigators will quantify absolute number of intracellular cytokine expression (TNF-a, IFNg, etc.) from each sample collected by mass cytometry (CyTOF) or flow cytometry
Changes in the mean fluorescent intensity of lymphocyte cell surface expression markers
BLOOD FOR ANALYSIS WILL BE DRAWN AT BASELINE (DAY 0), 3 WEEKS POST PEMBROLIZUMAB TREATMENT, AND 3 WEEKS POST PEMBROLIZUMAB PLUS ORAL BETA-GLUCAN
The investigators will quantify mean fluorescent intensity of lymphocyte cell surface (i.e., CD45, CD3, CD11b, etc.) from each sample collected by mass cytometry *CyTOF) or flow cytometry

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can melanoma be cured?

Melanoma is highly curable. The key to cure is early diagnosis and excision of the disease. With metastatic melanoma, curative surgery combined with appropriate adjuvant chemotherapy remains a treatment option to prolong life in the remaining days.

Anonymous Patient Answer

How many people get melanoma a year in the United States?

The incidence of all cancer may be higher because only the most important forms of cancer, such as breast and colorectal cancer, are captured by cancer registries. The most substantial increase in cancer is melanoma, because of the rapid increase in incidence of this potentially avoidable cancer. Because of the poor survival in melanoma, it is likely that some of the cases identified as "no survival" by the registries are not clinically significant.

Anonymous Patient Answer

What is melanoma?

The number of reported melanomas has doubled in the UK in the last ten years, reaching a level equivalent to the total number reported in the US, though many UK cases have not been diagnosed, or have been misdiagnosed. This is a worrying development. The average age of diagnosis of melanoma has declined markedly in the UK in the last 40 to 50 years. There are very good reasons for this reduction: improved reporting rates and the emergence of signs and symptoms, which is not the case in the US. Both these factors result in earlier recognition and treatment. The UK could lose 50 to 80% of its remaining melanomas by 2012.

Anonymous Patient Answer

What are the signs of melanoma?

There are 3 major signs of melanoma: itching, color change to a darker color and a mole or tumor. The presence of ulcers, a history of sun exposure and family history of melanoma may be helpful in an early diagnosis of melanoma.

Anonymous Patient Answer

What causes melanoma?

Most melanomas are acquired, whereas those caused by mutation have other genetic causes of susceptibility to metastasis and worse prognosis. Non-responding tumors have high mutation rates. Immunotherapy against melanoma is usually effective against metastatic melanomas, although it is important to monitor mutations and metastasis.

Anonymous Patient Answer

What are common treatments for melanoma?

Multiple options for treatment of melanoma exist for most Stage M melanomas. Survival for patients diagnosed in the United States was best when treatment was most likely to be provided by a multidisciplinary team. Patients of a more specific age, with Stage M lesions not of brain metastatic nature, or with melanoma of a primary site that was unlikely to recur after surgery should have more definitive, long term management options available.

Anonymous Patient Answer

What is the average age someone gets melanoma?

Melanomas occur at a younger age and in more Caucasian areas. This suggests that environmental effects are important. It can be a coincidence but people that get melanomas develop them at an age when they have been at their lowest point of productivity. The number of years that we have been having people around the people with melanoma is getting worse, and people are now at their lowest point.

Anonymous Patient Answer

What is the latest research for melanoma?

Melanoma may not be a type of cancer, but rather a group of very diverse cancers which have developed differently and therefore, may have different treatments available for their control. There are many more potential treatments than have ever been reported so if a “march in the valley” type of treatment for melanoma occurs, it will take a lot of work to understand which treatments work best for each patient and type of melanoma. One possible treatment is ipilimumab (called “anti-CTLA-4”).

Anonymous Patient Answer

What does beta-glucan usually treat?

Beta-Glucan has the potential to treat cancers of various types. There is still one condition where beta-glucans are well established as anti-cancer agents, even though the mechanism is unknown so far, and that is melanoma. Although there is the potential for a similar mechanism to be involved, an established treatment does not necessarily mean there needs to be a definitive mechanism. Thus, for those with melanomas, if a conventional anti-melanoma regimen is not effective in treating the melanoma, the introduction of betablockers as an adjunct to the therapy is an option worth considering.

Anonymous Patient Answer

Who should consider clinical trials for melanoma?

People can understand, and some find it a very positive step in getting treatment given to them for a debilitating disease. Clinical trials seem to be a good thing, especially in countries with a relatively limited healthcare system. There are many different types of clinical trials out there, but some basic guidelines such as the NCI-defined types of clinical trials, a list of patient demographics and some common cancers can help understand where the trial will be most helpful. Clinical trials for melanoma and the more common types of cancer often take place at large, multi-center, trials. There is usually a designated principal investigator who oversees all aspects of the study. One of the most common things of clinical trials is the use of placebo arms.

Anonymous Patient Answer

What are the latest developments in beta-glucan for therapeutic use?

There is active research to improve the therapeutic window of beta-glucan. Also, with the development of a beta-glc-glycolipid conjugate, the therapeutic window could be widened by overcoming the effect of the immunogenicity. Moreover, a new therapy with a liposomal formulation of beta-glucans could broaden the therapeutic window of beta-glucan. These are some of the current trends in beta-glucan for therapeutic use.

Anonymous Patient Answer

Have there been any new discoveries for treating melanoma?

The recent development of a BRAF (B-Raf/BRAF) inhibitor trametinib in early-stage melanoma is promising in that it might delay the development of resistance and hence could prolong survival after initial treatment failure.

Anonymous Patient Answer
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