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Riluzole + Sorafenib for Melanoma

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
Patients with brain lesions that have been treated with whole brain radiotherapy and are clinically stable for at least 4 weeks, are not taking steroids and are not receiving enzyme-inducing anticonvulsants will be eligible
Patients may have measurable or evaluable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing the combination of two drugs, sorafenib tosylate and riluzole, to treat patients with solid tumors or melanoma. The goal is to find the best dose of sorafenib tosylate that can be given with riluzole, and to learn about any side effects of the combination treatment.

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.Check my eligibility
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.See study design
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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My brain lesions were treated, I'm stable for 4 weeks, not on steroids or certain seizure meds.
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My cancer can be measured or observed.
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I can take care of myself but might not be able to do heavy physical work.
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My cancer is not responding to standard treatments, or there are none available for me.
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I have not used riluzole or sorafenib if I'm in the study's expansion phase and my tumor can be biopsied.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum-tolerated dose of sorafenib tosylate and riluzole in patients with all types of solid tumors
Secondary outcome measures
Change in BCL-2 expression
Change in BIM expression
Change in MCL-1 expression
+3 more

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
2005
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,611 Total Patients Enrolled
4 Trials studying Cutaneous Melanoma
198 Patients Enrolled for Cutaneous Melanoma
Janice M MehnertPrincipal InvestigatorRutgers Cancer Institute of New Jersey
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Riluzole (Other) Clinical Trial Eligibility Overview. Trial Name: NCT01303341 — Phase 1
Cutaneous Melanoma Research Study Groups: Treatment (riluzole and sorafenib tosylate)
Cutaneous Melanoma Clinical Trial 2023: Riluzole Highlights & Side Effects. Trial Name: NCT01303341 — Phase 1
Riluzole (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01303341 — Phase 1

Frequently Asked Questions

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

What other investigations have explored the use of Pharmacological Study?

"Currently, 66 trials focused on Pharmacological Study are in progress. 24 of those ongoing research efforts have reached the third phase while 2678 facilities around the world are running studies related to this medication. The majority of these sites can be found in Taibei, Taiwan."

Answered by AI

What conditions is Pharmacological Study typically used to treat?

"Pharmacological Study is most often prescribed for progressive, metastatic radioactive iodine-refractory differentiated thyroid carcinoma (dtc). Additionally, it has seen success when employed to treat gastrointestinal stromal tumors, hemangiosarcoma and leiomyosarcoma."

Answered by AI

Has the Pharmacological Study received regulatory acceptance from the FDA?

"With limited clinical evidence on its safety and efficacy, the pharmacological study received a rating of 1."

Answered by AI

Are there still openings for individuals to participate in this research?

"The information presented on clinicaltrials.gov confirms that this trial, which began posting in February of 2011 and was last updated in September 2022, is no longer recruiting participants. Despite this conclusion, there are numerous other medical studies currently searching for volunteers to join their trials."

Answered by AI

How many participants are taking part in this investigation?

"This trial has reached its recruitment cutoff, having been initially posted on February 18th 2011 and last updated on September 15th 2022. Those interested in participating in a clinical study can refer to the 3104 cancer trials or 66 Pharmacological Studies currently seeking participants."

Answered by AI
~2 spots leftby Mar 2025