Melanoma (Skin)
Conditions
Keywords
stage III melanoma, stage IV melanoma, recurrent melanoma
Brief summary
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.
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.
Interventions
100 mg orally twice daily
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response as Measured by RECIST Criteria | Imaging for tumor assessments was performed after 6 weeks | Per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) for target lesions and assessed by CT or MRI imaging: Complete response (CR) - disappearance of all target lesions; Partial response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) - At least a 20% increase in the sum of the longest diameter of target lesions; or Stable Disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With at Least One Adverse Event | From date of randomization through completion of follow-up, up to three years | Adverse events (AEs) were evaluated and graded using the National Cancer Institute Common Toxicity Criteria, version 3.0. |
| Overall Survival | Overall survival at one year | Kaplan-Meier plots of probability of overall survival. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Riluzole 100 mg orally twice daily
riluzole: 100 mg orally twice daily | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Riluzole |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 13 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 13 |
| other Total, other adverse events | 11 / 13 |
| serious Total, serious adverse events | 10 / 13 |
Outcome results
Tumor Response as Measured by RECIST Criteria
Per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) for target lesions and assessed by CT or MRI imaging: Complete response (CR) - disappearance of all target lesions; Partial response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) - At least a 20% increase in the sum of the longest diameter of target lesions; or Stable Disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time frame: Imaging for tumor assessments was performed after 6 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Riluzole | Tumor Response as Measured by RECIST Criteria | Stable disease | 6 Participants |
| Riluzole | Tumor Response as Measured by RECIST Criteria | Progressive disease | 7 Participants |
Number of Participants With at Least One Adverse Event
Adverse events (AEs) were evaluated and graded using the National Cancer Institute Common Toxicity Criteria, version 3.0.
Time frame: From date of randomization through completion of follow-up, up to three years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Riluzole | Number of Participants With at Least One Adverse Event | 9 Participants |
Overall Survival
Kaplan-Meier plots of probability of overall survival.
Time frame: Overall survival at one year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Riluzole | Overall Survival | 1 Participants |