Status:
TERMINATED
Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 patien...
Detailed Description
OBJECTIVES: Primary * To evaluate the potential effects of glutamate receptor blockade on cellular pathways important in the genesis and progression of melanoma in patients with stage III or IV mela...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00667901
Start Date
February 1 2007
End Date
November 1 2008
Last Update
December 11 2009
Active Locations (1)
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1
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903