Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30CA072720 | U.S. NIH Grant/Contract | View source | |
| CINJ-090603 | |||
| CINJ-IRB-0220060225 |
Not provided
Not provided
Not provided
All enrollment, treatment, follow-up & data analysis completed
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 early phase I trial is studying how well riluzole works in treating patients with stage III or stage IV melanoma that can be removed by surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral riluzole twice daily for 14 days. Within 24 hours after the final dose of riluzole, patients undergo standard surgical resection.
Patients undergo tumor tissue sample collection at baseline and during surgery for laboratory studies. Samples are analyzed by routine histology, immunohistochemistry, western blotting, and RT-PCR for Grm1 expression, - RAS and B-raf mutations, PLC and MAP kinase activity, Ki-67 staining, and mitotic rate. Patients also undergo blood sample collection periodically for pharmacokinetics studies.
PET scans are obtained before and after treatment to evaluate the overall metabolic activity of the tumor and how this activity changes with inhibition of the Grm1 pathway.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| riluzole | Drug | |||
| protein expression analysis | Genetic | |||
| reverse transcriptase-polymerase chain reaction | Genetic | |||
| western blotting | Genetic | |||
| immunohistochemistry staining method | Other | |||
| laboratory biomarker analysis | Other | |||
| pharmacological study | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the inhibition of components of the Grm1 signaling cascade |
| Measure | Description | Time Frame |
|---|---|---|
| Mitoses in nodal metastases and Ki-67 immunostaining (0-3+ scale) |
Not provided
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed melanoma
Must have at least two resectable tumors or a tumor large enough to undergo pre-treatment core needle biopsy
Must be eligible for resection of disease with curative or palliative intent
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Not provided
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 |
|---|---|---|---|---|---|---|
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| neoadjuvant therapy | Procedure |
| therapeutic conventional surgery | Procedure |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D019782 | Riluzole |
| D020133 | Reverse Transcriptase Polymerase Chain Reaction |
| D015153 | Blotting, Western |
| D007150 | Immunohistochemistry |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D052160 | Benzothiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D004586 | Electrophoresis |
| D002623 | Chemistry Techniques, Analytical |
| D055664 | Electrochemical Techniques |
| D015151 | Immunoblotting |
| D007118 | Immunoassay |
| D007158 | Immunologic Techniques |
| D015336 | Molecular Probe Techniques |
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
Not provided
Not provided