Clinical trial · Interventional
Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery
A Phase 0 Trial of Riluzole in Patients With Resectable Stage III and IV Melanoma
NCT00667901CI-TRIAL-00002884terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): All enrollment, treatment, follow-up \& data analysis completed
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
| reverse transcriptase-polymerase chain reaction | Genetic | — | UNRESOLVED |
| riluzole | Drug | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Measurement of the inhibition of components of the Grm1 signaling cascade
Secondary outcomes (1)
- measure
- Mitoses in nodal metastases and Ki-67 immunostaining (0-3+ scale)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed melanoma * Stage III or IV disease * 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: * ECOG performance status 0 or 1 * ANC ≥ 1,000/mm³ * Platelet count ≥ 50,000/mm³ * AST/ALT ≤ 3 times upper limit of normal (ULN) * Total bilirubin normal * Calculated creatinine clearance ≥ 50 mL/min * INR ≤ 25% of ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 48 hours after completion of study treatment * No history of allergic reaction to riluzole or similar compounds * No known history of hepatitis B or C PRIOR CONCURRENT THERAPY: * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.