Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00667901
• Other study ID #: CDR0000592958
• Secondary ID: P30CA072720CINJ-
• Status: Terminated
• Phase: Phase 1
• First received: April 25, 2008
• Last updated: December 10, 2009
• Start date: February 2007
• Est. completion date: November 2008

Study information

• Verified date: December 2009
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 patients with stage III or stage IV melanoma that can be removed by surgery.

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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Drug:
• riluzole

Genetic:
• protein expression analysis

• reverse transcriptase-polymerase chain reaction

• western blotting

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

• pharmacological study

Procedure:
• neoadjuvant therapy

• therapeutic conventional surgery

Locations

Country	Name	City	State
United States	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of the inhibition of components of the Grm1 signaling cascade			No
Secondary	Mitoses in nodal metastases and Ki-67 immunostaining (0-3+ scale)			No