Riluzole and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors or Melanoma
A Phase I Trial of Riluzole and Sorafenib in Patients With Advanced Solid Tumors and Melanoma
8 other identifiers
interventional
35
1 country
1
Brief Summary
This phase I trial studies the side effects and best dose of sorafenib tosylate when given together with riluzole in treating patients with solid tumors or melanoma that has spread to other places in the body and usually cannot be cured or controlled with treatment. Riluzole may stop or slow the growth of tumor cells. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving riluzole together with sorafenib tosylate may kill more tumor cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2011
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 18, 2011
CompletedFirst Submitted
Initial submission to the registry
February 22, 2011
CompletedFirst Posted
Study publicly available on registry
February 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 17, 2026
ExpectedApril 13, 2026
March 1, 2026
1.2 years
February 22, 2011
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum-tolerated dose of sorafenib tosylate and riluzole in patients with all types of solid tumors
Maximum tolerated dose is defined as the first dose level at which exactly 2/6 patients experience dose limiting toxicity, or at which 1/6 experience dose limiting toxicity and (due to de-escalation) at least 2/3 or 3/6 patients treated with the next higher dose level had dose limiting toxicity.
28 days
Secondary Outcomes (6)
Suppression of MAPK and PI3K/AKT pathways
Up to 3 years
Change in BCL-2 expression
Baseline to 3 years
Change in MCL-1 expression
Baseline to 3 years
Change in BIM expression
Baseline to 3 years
Pharmacokinetic parameters of the combination of riluzole with sorafenib tosylate
On days 2, 8, 10, and 15 of each course
- +1 more secondary outcomes
Study Arms (1)
Treatment (riluzole and sorafenib tosylate)
EXPERIMENTALPatients 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.
Interventions
Given PO
Eligibility Criteria
You may qualify if:
- Patients must have histologically proven solid tumors (Phase I) with biopsiable tumor (expansion cohort) refractory to standard therapy or for whom no standard therapy exists or who decline standard therapy
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Patients must be willing and able to sign informed consent
- Unlimited prior therapies are permitted for patients enrolled in the dose escalation phase of the study; patients in the expansion cohort of the study may not have any prior therapy with riluzole or sorafenib and must have biopsiable tumor
- Patients may have measurable or evaluable disease
- Absolute neutrophil count (ANC) \>= 1,500/uL
- Platelets \>= 100,000/uL
- Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN
- International normalized ratio (INR) =\< 1.5 x institutional ULN
- Creatinine =\< 2 x ULN
- 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
You may not qualify if:
- Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
- For patients who have received gamma knife or stereotactic radiosurgery, a 2 week washout is required; patients who have had other types of radiotherapy, chemotherapy or biologic agents within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier to =\< grade 1; at least 4 weeks must have elapsed since any major surgery; patients with prostate cancer may continue to receive hormonal therapy
- History of allergic reactions attributed to riluzole or sorafenib
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal, barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for 2 weeks after discontinuation of riluzole and/or sorafenib; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; pregnant (positive pregnancy test) or lactating patients cannot participate
- Known human immunodeficiency virus (HIV) infection or known history of active hepatitis B or C infection
- Current, recent (within 4 weeks of the first treatment of this study), or planned participation in an experimental drug study (prevention trials are permitted if the trial is not testing a novel experimental agent)
- Cardiac disease: congestive heart failure \> class II New York Heart Association (NYHA); patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
- History of stroke within six months
- Clinically significant peripheral vascular disease
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Uncontrolled hypertension, defined as systolic blood pressure \> 150 mm Hg or diastolic blood pressure \> 90 mm Hg, despite optimal medical management
- Active clinically serious infection \> Common Terminology Criteria for Adverse Events (CTCAE) grade 2
- Any of the following within 6 months prior to first dose of treatment: myocardial infarction, symptomatic coronary artery disease (severe or unstable angina), artery bypass graft, uncontrolled arrhythmias, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolus
- Pulmonary hemorrhage/bleeding event \>= CTCAE grade 2 within 4 weeks of first-dose of study drug
- Any other hemorrhage/bleeding event \>= CTCAE grade 3 within 4 weeks of first dose of study drug
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Related Publications (1)
Spencer KR, Portal DE, Aisner J, Stein MN, Malhotra J, Shih W, Chan N, Silk AW, Ganesan S, Goodin S, Gounder M, Lin H, Li J, Cerchio R, Marinaro C, Chen S, Mehnert JM. A phase I trial of riluzole and sorafenib in patients with advanced solid tumors: CTEP #8850. Oncotarget. 2023 Apr 10;14:302-315. doi: 10.18632/oncotarget.28403.
PMID: 37036756DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janice M Mehnert
Rutgers Cancer Institute of New Jersey
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2011
First Posted
February 24, 2011
Study Start
February 18, 2011
Primary Completion
May 1, 2012
Study Completion (Estimated)
September 17, 2026
Last Updated
April 13, 2026
Record last verified: 2026-03