Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
This study is ongoing, but not recruiting participants.
Sponsor:
University of Medicine and Dentistry New Jersey
Collaborator:
Information provided by (Responsible Party):
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00866840
First received: March 20, 2009
Last updated: November 9, 2012
Last verified: November 2012
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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 phase II trial is studying how well riluzole works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Drug: riluzole |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Riluzole in Patients With Advanced Melanoma |
Resource links provided by NLM:
Further study details as provided by University of Medicine and Dentistry New Jersey:
Primary Outcome Measures:
- Tumor shrinkage, as measured by RECIST criteria [ Time Frame: Treatment start date to date of best response ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Long-term toxicity of riluzole, as measured by NCI CTCAE version 3.0 [ Time Frame: Treatment start date through follow-up ] [ Designated as safety issue: Yes ]
- Survival [ Time Frame: Treatment start date to date of death ] [ Designated as safety issue: No ]
| Enrollment: | 13 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Riluzole
100 mg orally twice daily
|
Drug: riluzole
100 mg orally twice daily
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866840
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: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00866840 History of Changes |
| Other Study ID Numbers: | CDR0000637646, P30CA072720, CINJ-090802 |
| Study First Received: | March 20, 2009 |
| Last Updated: | November 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Medicine and Dentistry New Jersey:
|
stage III melanoma stage IV melanoma recurrent 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 18, 2013