Phase 2
N=13
Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Melanoma (Skin)
Bottom Line
View on ClinicalTrials.gov: NCT00866840 ↗Enrolled (actual)
13
Serious AEs
76.9%
Results posted
Sep 2022
Primary outcome: Primary: Tumor Response as Measured by RECIST Criteria — 6; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- riluzole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Response as Measured by RECIST Criteria |
6; 7 | — |
| SECONDARY Number of Participants With at Least One Adverse Event |
9 | — |
| SECONDARY Overall Survival |
1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00866840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.