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A Phase 0 Trial of Riluzole in Patients With Resectable Stage III and IV Melanoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

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Trial Information

A Phase 0 Trial of Riluzole in Patients With Resectable Stage III and IV Melanoma


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
melanoma undergoing surgical resection.

- To determine whether treatment with riluzole alters expression of activated PLC and ERK
in lysates from tumor tissue biopsies.

Secondary

- Determine if treatment with riluzole affects the overall metabolic activity of melanoma
tumors as measured by pre- and post-treatment PET scanning, pre- and post-treatment
tumor mitotic rate evaluation, and pre- and post-treatment immunohistochemical staining
for Ki-67.

OUTLINE: Patients receive oral riluzole twice daily for 14 days. Within 24 hours after the
final dose of riluzole, patients undergo standard surgical resection.

Patients undergo tumor tissue sample collection at baseline and during surgery for
laboratory studies. Samples are analyzed by routine histology, immunohistochemistry, western
blotting, and RT-PCR for Grm1 expression, - RAS and B-raf mutations, PLC and MAP kinase
activity, Ki-67 staining, and mitotic rate. Patients also undergo blood sample collection
periodically for pharmacokinetics studies.

PET scans are obtained before and after treatment to evaluate the overall metabolic activity
of the tumor and how this activity changes with inhibition of the Grm1 pathway.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Measurement of the inhibition of components of the Grm1 signaling cascade

Safety Issue:

No

Principal Investigator

James S. Goydos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Federal Government

Study ID:

CDR0000592958

NCT ID:

NCT00667901

Start Date:

February 2007

Completion Date:

November 2008

Related Keywords:

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

Name

Location

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