Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30CA072720 | U.S. NIH Grant/Contract | View source | |
| CINJ-090802 | Other Identifier | CINJ | |
| CDR0000637646 | Other Identifier | CDR |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
Primary
Secondary
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Riluzole | Experimental | 100 mg orally twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| riluzole | Drug | 100 mg orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Imaging for tumor assessments was performed after 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From date of randomization through completion of follow-up, up to three years |
| Overall Survival |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed malignant melanoma
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:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James S. Goydos, MD | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29453787 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Riluzole | 100 mg orally twice daily riluzole: 100 mg orally twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Riluzole | 100 mg orally twice daily riluzole: 100 mg orally twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Imaging for tumor assessments was performed after 6 weeks |
|
From date of randomization through completion of follow-up, up to three years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Riluzole | 100 mg orally twice daily riluzole: 100 mg orally twice daily | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Goydos, MD | Rutgers Cancer Institute of New Jersey | (732) 235-7593 | goydosjs@cinj.rutgers.edu |
Not provided
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D019782 | Riluzole |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D052160 | Benzothiazoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Kaplan-Meier plots of probability of overall survival. |
| Overall survival at one year |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| 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. | Posted | Count of Participants | Participants | From date of randomization through completion of follow-up, up to three years |
|
|
|
| Secondary | Overall Survival | Kaplan-Meier plots of probability of overall survival. | Posted | Count of Participants | Participants | Overall survival at one year |
|
|
|
| 13 |
| 10 |
| 13 |
| 11 |
| 13 |
| Muscle weakness, generalized or specific area | General disorders | Systematic Assessment | (not due to neuropathy) - Extremity-upper |
|
| Death | General disorders | Systematic Assessment | not associated with CTCAE term - Disease progression NOS |
|
| Infection | Infections and infestations | Systematic Assessment | with normal ANC or Grade 1 or 2 neutrophils - Abdomen NOS |
|
| Dehydration | General disorders | Systematic Assessment |
|
| Speech impairment (e.g., dysphasia or aphasia) | Nervous system disorders | Systematic Assessment |
|
| Pain - Extremity-limb | General disorders | Systematic Assessment | left arm |
|
| Neuropathy: motor | Nervous system disorders | Systematic Assessment |
|
| Constitutional Symptoms | Gastrointestinal disorders | Systematic Assessment |
|
| Neurology | Nervous system disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Metabolic/Laboratory | Metabolism and nutrition disorders | Systematic Assessment |
|
| Musculoskeletal/Soft Tissue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Blood/Bone Marrow | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pulmonary/Upper Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cardiac General | Cardiac disorders | Systematic Assessment |
|
| Dermatology/Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Ocular/Visual | Eye disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |