Status:
COMPLETED
Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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 wi...
Detailed Description
OBJECTIVES: Primary * Determine whether administration of a daily dose of riluzole results in tumor shrinkage, as measured by RECIST criteria, in patients with advanced melanoma. Secondary * Deter...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00866840
Start Date
April 1 2009
End Date
July 1 2013
Last Update
January 19 2024
Active Locations (1)
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1
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903