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Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

A Phase II Trial of Riluzole in Patients With Advanced Melanoma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00866840
Enrollment
13
Registered
2009-03-23
Start date
2009-04-30
Completion date
2013-07-31
Last updated
2024-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

Keywords

stage III melanoma, stage IV melanoma, recurrent melanoma

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.

Interventions

DRUGriluzole

100 mg orally twice daily

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Tumor Response as Measured by RECIST CriteriaImaging for tumor assessments was performed after 6 weeksPer Response Evaluation Criteria in Solid Tumors (RECIST v1.0) for target lesions and assessed by CT or MRI imaging: Complete response (CR) - disappearance of all target lesions; Partial response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) - At least a 20% increase in the sum of the longest diameter of target lesions; or Stable Disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Secondary

MeasureTime frameDescription
Number of Participants With at Least One Adverse EventFrom date of randomization through completion of follow-up, up to three yearsAdverse events (AEs) were evaluated and graded using the National Cancer Institute Common Toxicity Criteria, version 3.0.
Overall SurvivalOverall survival at one yearKaplan-Meier plots of probability of overall survival.

Countries

United States

Participant flow

Participants by arm

ArmCount
Riluzole
100 mg orally twice daily riluzole: 100 mg orally twice daily
13
Total13

Baseline characteristics

CharacteristicRiluzole
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
9 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
13 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
13 Participants
Region of Enrollment
United States
13 Participants
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
7 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
4 / 13
other
Total, other adverse events
11 / 13
serious
Total, serious adverse events
10 / 13

Outcome results

Primary

Tumor Response as Measured by RECIST Criteria

Per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) for target lesions and assessed by CT or MRI imaging: Complete response (CR) - disappearance of all target lesions; Partial response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) - At least a 20% increase in the sum of the longest diameter of target lesions; or Stable Disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Time frame: Imaging for tumor assessments was performed after 6 weeks

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
RiluzoleTumor Response as Measured by RECIST CriteriaStable disease6 Participants
RiluzoleTumor Response as Measured by RECIST CriteriaProgressive disease7 Participants
Comparison: No objective responses were seen in the first phase and accrual was stopped.
Secondary

Number of Participants With at Least One Adverse Event

Adverse events (AEs) were evaluated and graded using the National Cancer Institute Common Toxicity Criteria, version 3.0.

Time frame: From date of randomization through completion of follow-up, up to three years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
RiluzoleNumber of Participants With at Least One Adverse Event9 Participants
Secondary

Overall Survival

Kaplan-Meier plots of probability of overall survival.

Time frame: Overall survival at one year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
RiluzoleOverall Survival1 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026