Riluzole and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors or Melanoma (NCT01303341) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Riluzole and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors or Melanoma
United States35 participantsStarted 2011-02-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient's ability to complete t…
What they're measuring
1
Maximum-tolerated dose of sorafenib tosylate and riluzole in patients with all types of solid tumors