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A Phase II Trial of Riluzole in Patients With Advanced Melanoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin)

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Trial Information

A Phase II Trial of Riluzole in Patients With Advanced Melanoma


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

- Determine the long-term toxicity of riluzole when administered to these patients.

- Compare the survival of these patients with historical controls.

OUTLINE: Patients receive oral riluzole twice daily on days 1-28. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor shrinkage, as measured by RECIST criteria

Outcome Time Frame:

Treatment start date to date of best response

Safety Issue:

No

Principal Investigator

James S. Goydos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000637646

NCT ID:

NCT00866840

Start Date:

April 2009

Completion Date:

December 2014

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903