What side effects are associated with this type of intervention?

Common treatments for melanoma, particularly those involving immune enhancement such as checkpoint inhibitors (e.g., pembrolizumab, nivolumab), often have side effects related to immune system activation. These can include fatigue, rash, diarrhea, and more severe immune-related adverse events like pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. These side effects occur because the immune system may attack normal organs and tissues in addition to the cancer cells.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of melanoma. Pembrolizumab and nivolumab, both PD-1 inhibitors, have been approved for advanced or metastatic melanoma. Nivolumab is also approved in combination with ipilimumab, a CTLA-4 inhibitor, for enhanced efficacy. These treatments work by enhancing the body's immune response against cancer cells. The combination of these drugs has shown improved outcomes in terms of progression-free survival and overall survival in patients with advanced melanoma.

What other types of research exist?

<ol> <li>Beta-glucans: Various sources of beta-glucans, particularly from yeast, have shown enhanced therapeutic efficacy when combined with anti-tumor monoclonal antibodies in murine tumor models.</li> </ol> They have demonstrated the ability to reduce tumor burden and improve long-term survival. 2. Organic Germanium (Ge-132): This compound has immune-modulating effects and, when combined with lactobacilli and oligosaccharides, has been shown to stimulate intestinal immunity, which could be beneficial for overall immune support in cancer patients. 3. Cordyceps militaris fermented with Pediococcus pentosaceus (GRC-ON89A): This combination has shown immune-enhancing activity in immunosuppressed models, suggesting potential benefits for cancer patients needing immune support.

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Fermented Wheat Germ Extract for Cancer

Phase 1

Recruiting

Led By Joseph M Tuscano

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

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

Must have

Must be able to swallow study treatment

Histologically or cytologically confirmed non small cell lung carcinoma (NSCLC), renal cell carcinoma (RCC), melanoma, colorectal carcinoma (CRC) and triple-negative breast cancer (TNBC) solid tumor malignancies deemed appropriate to receive standard-of-care CPi-based therapy

Must not have

Must not have received live, attenuated influenza vaccine within 4 weeks prior to cycle 1, day 1 or at any time during the study

Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of FWG

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 57

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a nutritional supplement called fermented wheat germ can help boost the immune system in patients with advanced solid tumors who are already receiving standard cancer treatments. The goal is to see if this supplement can improve the effectiveness of their current therapy by enhancing immune cell activity.

Who is the study for?

Adults with advanced solid tumors (like lung, kidney, skin cancers) who are already on checkpoint inhibitors can join. They must be able to swallow pills, have a life expectancy over 6 months, and use birth control. People can't join if they've had certain vaccines recently, are already taking the supplement being tested or other immune treatments, have uncontrolled illnesses or allergies to similar compounds.

What is being tested?

This trial is testing fermented wheat germ as a nutritional supplement alongside standard cancer immunotherapy drugs called checkpoint inhibitors. Researchers want to see if it improves the immune system's response against cancer in patients with advanced solid tumors.

What are the potential side effects?

Since fermented wheat germ is a nutritional supplement rather than a drug, specific side effects aren't well-documented but could include digestive issues due to its fiber content. Allergic reactions may occur in those sensitive to gluten or related compounds.

Eligibility Criteria

Inclusion Criteria

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

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I can swallow pills.

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My cancer is one of NSCLC, RCC, melanoma, CRC, or TNBC and can be treated with CPi therapy.

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I am 18 years old or older.

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I can take care of myself but might not be able to do active work.

Exclusion Criteria

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

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I have not had a live flu vaccine in the last 4 weeks.

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I have not received a live vaccine in the last 4 weeks and do not plan to during the study.

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I do not have any severe illnesses or social situations that could affect my safety or participation in the study.

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I have active tuberculosis.

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I am not pregnant or breastfeeding.

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I have had a bone marrow or organ transplant in the past.

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I haven't had major surgery in the last 28 days and don't expect to need one during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 57

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 57

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 57 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Natural killer (NK) cell killing activity

Secondary study objectives

Immunologic effects of FWG (Immune Correlates): T-reg cell function

Immunologic effects of FWG (Immune Correlates): assay of T cell proliferation, cytokine production and cytotoxic lymphocyte (CTL) activity

Immunologic effects of FWG (Immune Correlates): distribution of mononuclear cell subsets

+2 more

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: Fermented wheat germExperimental Treatment1 Intervention

Patients receive fermented wheat germ PO daily starting 3 days prior to the start of standard of care checkpoint inhibitor therapy on days 1-56 for 8 weeks. Patients undergo blood sample collection during screening, on days 1, 4, 15, 43 and at the end of treatment visit. Patients undergo stool sample collection during screening, day 1, 4 and at the end of treatment visit.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for melanoma, particularly advanced cases, often involve immunotherapy. This includes checkpoint inhibitors like nivolumab and ipilimumab, which work by blocking proteins that prevent T-cells from attacking cancer cells, thereby enhancing the immune response against tumors. Another approach is the use of therapeutic vaccines, such as those involving autologous tumor-infiltrating lymphocytes, which aim to boost the body's immune system to recognize and destroy melanoma cells. The potential immune enhancement from supplements like fermented wheat germ is being studied to determine if it can further support the immune system in its fight against cancer. These treatments are crucial for melanoma patients as they offer a targeted approach to harnessing the body's own defenses to combat the disease, potentially leading to better outcomes and prolonged survival.

The gluttonous side of malignant melanoma: basic and clinical implications of macroautophagy.