What side effects are associated with this type of intervention?

Common treatments for cutaneous melanoma, such as riluzole and sorafenib tosylate, have several known side effects. Riluzole may cause nausea, fatigue, and liver function abnormalities. Sorafenib tosylate, a kinase inhibitor, is associated with dermatological toxicities such as hand-foot skin reactions, rash, and alopecia. Additionally, it can cause hypertension, diarrhea, and fatigue. Patients undergoing these treatments should be closely monitored for these adverse effects to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Cutaneous Melanoma that are similar to Riluzole and Sorafenib Tosylate. Sorafenib Tosylate, a kinase inhibitor, is similar to other FDA-approved kinase inhibitors like Vemurafenib and Dabrafenib, which target the BRAF mutation in melanoma. Additionally, the FDA has approved other kinase inhibitors such as Trametinib, which targets MEK, a downstream component of the BRAF pathway. While Riluzole's mechanism of inhibiting tumor cell proliferation is less common in FDA-approved melanoma treatments, other drugs like Pembrolizumab and Nivolumab, which are immune checkpoint inhibitors, also aim to reduce tumor growth by enhancing the body's immune response against cancer cells.

What other types of research exist?

Promising novel alternatives for cutaneous melanoma treatment include BRAF inhibitors like vemurafenib and dabrafenib, especially when combined with MEK inhibitors such as trametinib. Additionally, immune checkpoint inhibitors like pembrolizumab and nivolumab, as well as combination therapies involving these agents, are showing significant efficacy in clinical trials.

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Riluzole + Sorafenib for Melanoma

Q: What is the mechanism of action of this treatment?

Riluzole inhibits tumor cell proliferation, effectively slowing down or stopping the growth of melanoma cells. Sorafenib Tosylate, a kinase inhibitor, blocks specific enzymes required for tumor cell growth, preventing cancer progression. These mechanisms are vital for cutaneous melanoma patients as they target the cancer at the cellular level, offering a strategic approach to manage and potentially control the disease.

Phase 1

Waitlist Available

Led By Janice M Mehnert

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status =< 2

Be older than 18 years old

Must not have

History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 1 of treatment

Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety and best dose of combining riluzole and sorafenib tosylate for patients with advanced solid tumors or melanoma that don't respond to standard treatments. Riluzole may slow tumor growth, and sorafenib tosylate blocks processes needed for tumor growth. The combination aims to kill more tumor cells.

Who is the study for?

This trial is for adults with advanced solid tumors or melanoma that's spread and can't be cured or controlled. They must have proper liver, kidney, and blood function, no serious wounds or infections, and not be on certain drugs affecting the liver enzymes. Pregnant women can't join; participants must use birth control.

What is being tested?

The trial tests combining Riluzole with Sorafenib Tosylate to see if they're more effective together against tumor growth in patients with advanced cancer. It aims to find the safest dose of Sorafenib when used with Riluzole by monitoring how patients' bodies respond.

What are the potential side effects?

Possible side effects include difficulty swallowing pills due to mouth sores, allergic reactions to either drug, increased risk of bleeding events or wound healing complications, high blood pressure management issues, and potential heart problems.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

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

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I haven't had any major abdominal issues like a fistula, perforation, or abscess in the last 6 months.

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I need medication for irregular heartbeats.

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I have not had a serious lung bleeding event in the last 4 weeks.

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I have not had severe bleeding in the last 4 weeks.

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My heart condition is stable, and I haven't had a heart attack in the last 6 months.

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My blood pressure is not controlled, even with medication.

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I have serious blood vessel problems in my arms or legs.

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I do not have a serious infection worse than a moderate level.

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I have a history of bleeding disorders.

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I have a serious wound or fracture that is not healing.

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I am allergic to riluzole or sorafenib.

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I haven't had a heart attack, severe heart disease, stroke, or blood clots in the last 6 months.

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I have not had major surgery or a significant injury in the last 4 weeks.

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I expect to need a major surgery during the study.

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I have HIV or active hepatitis B or C.

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I have issues absorbing nutrients from my food.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum-tolerated dose of sorafenib tosylate and riluzole in patients with all types of solid tumors

Secondary study objectives

Change in BCL-2 expression

Change in BIM expression

Change in MCL-1 expression

+3 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: Treatment (riluzole and sorafenib tosylate)Experimental Treatment4 Interventions

Patients receive riluzole PO BID and sorafenib tosylate PO QD or BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Riluzole

2006

Completed Phase 4

~2780

Sorafenib Tosylate

2015

Completed Phase 3

~3680

0 / 17Eligibility 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

Riluzole inhibits tumor cell proliferation, effectively slowing down or stopping the growth of melanoma cells. Sorafenib Tosylate, a kinase inhibitor, blocks specific enzymes required for tumor cell growth, preventing cancer progression. These mechanisms are vital for cutaneous melanoma patients as they target the cancer at the cellular level, offering a strategic approach to manage and potentially control the disease.