NCT01303341

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To define a safe dose of sorafenib (sorafenib tosylate) to combine with riluzole in the treatment of patients with all types of solid tumors refractory to standard therapy or for whom no standard therapy exists. SECONDARY OBJECTIVES: I. To examine the correlation of clinical or radiologic response with signaling through the mitogen-activated protein kinase (MAPK) and phosphoinositide 3-kinase (PI3K)/protein kinase B (AKT) pathways. II. To determine if response to therapy with riluzole and sorafenib correlates with expression levels of B-cell lymphoma (BCL)-2, myeloid cell leukemia (MCL)-1, or BCL2-like 11 (apoptosis facilitator) (BIM). III. To characterize the pharmacokinetics of the combination of riluzole with sorafenib and determine if any drug-drug interactions exist. IV. To evaluate the microvesicle (an inter-cellular communication approach which may cargo proteins, ribonucleic acids \[RNAs\] and deoxyribonucleic acids \[DNAs\] to its host cell) quantification difference between pre-treatment and post-treatment peripheral blood samples of patients. OUTLINE: This is a dose-escalation study of sorafenib tosylate. Patients receive riluzole orally (PO) twice daily (BID) and sorafenib tosylate PO once daily (QD) or BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up for approximately 2-3 years.

Conditions

• Advanced Malignant Solid Neoplasm
• Recurrent Melanoma
• Refractory Malignant Solid Neoplasm
• Stage III Cutaneous Melanoma AJCC v7
• Stage IIIA Cutaneous Melanoma AJCC v7
• Stage IIIB Cutaneous Melanoma AJCC v7
• Stage IIIC Cutaneous Melanoma AJCC v7
• Stage IV Cutaneous Melanoma AJCC v6 and v7

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
DRUG	Riluzole	Given PO
DRUG	Sorafenib Tosylate	Given PO

Timeline

• Start date: 2011-02-18
• Primary completion: 2012-05-01
• Completion: 2026-09-17
• First posted: 2011-02-24
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States