Clinical trial NCT00866840: Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Official title: A Phase II Trial of Riluzole in Patients With Advanced Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma (Skin)
Keywords: stage III melanoma
stage IV melanoma
recurrent melanoma
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-03-23
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Riluzole may stop or slow the growth of tumor cells and may be an effective treatment for melanoma.

PURPOSE: This phase II trial is studying how well riluzole works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.

Detailed description: OBJECTIVES:

Primary

* Determine whether administration of a daily dose of riluzole results in tumor shrinkage, as measured by RECIST criteria, in patients with advanced melanoma.

Secondary

* Determine the long-term toxicity of riluzole when administered to these patients.
* Compare the survival of these patients with historical controls.

OUTLINE: Patients receive oral riluzole twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed malignant melanoma

  * Unresectable stage III or stage IV disease
* Measurable disease according to RECIST criteria, defined as ≥ 1 unidimensionally measurable lesion \> 20 mm by conventional techniques or \> 10 mm by spiral CT scan
* No known brain metastases unless treated and stable for ≥ 2 weeks by MRI evaluation

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* ANC ≥ 1,000/μL
* Platelet count ≥ 50,000/μL
* Total bilirubin ≤ 2 times upper limit of normal (ULN)
* AST/ALT ≤ 3 times ULN
* INR ≤ 1.5 times ULN
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 weeks after completion of study treatment
* No second primary malignancy, except carcinoma in situ of the cervix, adequately treated nonmelanoma carcinoma of the skin, or other malignancy treated ≥ 5 years ago with no evidence of recurrence
* No concurrent serious systemic disorders (including active infections) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
* No history of allergic reactions attributed to riluzole
* No known history of hepatitis B or C

PRIOR CONCURRENT THERAPY:

* No more than 1 prior therapeutic chemotherapy regimen for advanced melanoma
* Prior treatment with riluzole on clinical trial CINJ-090603 allowed
* No other concurrent investigational or commercial agents or therapies for the treatment of the malignancy

Primary outcomes:
measure: Tumor Response as Measured by RECIST Criteria
timeFrame: Imaging for tumor assessments was performed after 6 weeks
Secondary outcomes:
measure: Number of Participants With at Least One Adverse Event
timeFrame: From date of randomization through completion of follow-up, up to three years
measure: Overall Survival
timeFrame: Overall survival at one year
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: James S. Goydos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mehnert JM, Silk AW, Lee JH, Dudek L, Jeong BS, Li J, Schenkel JM, Sadimin E, Kane M, Lin H, Shih WJ, Zloza A, Chen S, Goydos JS. A phase II trial of riluzole, an antagonist of metabotropic glutamate receptor 1 (GRM1) signaling, in patients with advanced melanoma. Pigment Cell Melanoma Res. 2018 Jul;31(4):534-540. doi: 10.1111/pcmr.12694. Epub 2018 Apr 10.