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Phase 2 N=13 Treatment

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

Melanoma (Skin)

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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