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

Sponsor:	University of Medicine and Dentistry New Jersey
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00667901

Purpose

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.

Condition	Intervention	Phase
Melanoma (Skin)	Drug: riluzole Genetic: protein expression analysis Genetic: reverse transcriptase-polymerase chain reaction Genetic: western blotting Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacological study Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase 0 Trial of Riluzole in Patients With Resectable Stage III and IV Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma Surgery

Drug Information available for: Riluzole

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:

Measurement of the inhibition of components of the Grm1 signaling cascade [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mitoses in nodal metastases and Ki-67 immunostaining (0-3+ scale) [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	February 2007
Study Completion Date:	November 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667901

Locations

United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903

Sponsors and Collaborators

University of Medicine and Dentistry New Jersey

National Cancer Institute (NCI)

Investigators

Principal Investigator:

James S. Goydos, MD

Cancer Institute of New Jersey

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UMDNJ/CINJ ( James Goydos, MD )
Study ID Numbers:	CDR0000592958, P30CA072720, CINJ-090603, CINJ-IRB-0220060225
Study First Received:	April 25, 2008
Last Updated:	December 10, 2009
ClinicalTrials.gov Identifier:	NCT00667901 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by University of Medicine and Dentistry New Jersey:

stage III melanoma
stage IV melanoma

Additional relevant MeSH terms:

Riluzole
Neurotransmitter Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Excitatory Amino Acid Agents
Protective Agents
Neuroprotective Agents
Pharmacologic Actions

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Central Nervous System Agents
Anticonvulsants
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on February 08, 2010