Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery
This study has been terminated.
(All enrollment, treatment, follow-up & data analysis completed)
Sponsor:
University of Medicine and Dentistry New Jersey
Collaborator:
Information provided by:
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00667901
First received: April 25, 2008
Last updated: December 10, 2009
Last verified: December 2009
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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 1 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 0 Trial of Riluzole in Patients With Resectable Stage III and IV Melanoma |
Resource links provided by NLM:
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) |
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
Investigators
| Principal Investigator: | James S. Goydos, MD | Cancer Institute of New Jersey |
More Information
Additional Information:
No publications provided
| Responsible Party: | James Goydos, MD, UMDNJ/CINJ |
| ClinicalTrials.gov Identifier: | NCT00667901 History of Changes |
| Other Study ID Numbers: | CDR0000592958, P30CA072720, CINJ-090603, CINJ-IRB-0220060225 |
| Study First Received: | April 25, 2008 |
| Last Updated: | December 10, 2009 |
| 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:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Riluzole Excitatory Amino Acid Antagonists |
Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Neuroprotective Agents Protective Agents Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on June 17, 2013