Trial Outcomes & Findings for Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery (NCT NCT00866840)
NCT ID: NCT00866840
Last Updated: 2024-01-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Imaging for tumor assessments was performed after 6 weeks
Results posted on
2024-01-19
Participant Flow
Participant milestones
| Measure |
Riluzole
100 mg orally twice daily
riluzole: 100 mg orally twice daily
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Riluzole
n=13 Participants
100 mg orally twice daily
riluzole: 100 mg orally twice daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Imaging for tumor assessments was performed after 6 weeksPer 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.
Outcome measures
| Measure |
Riluzole
n=13 Participants
100 mg orally twice daily
riluzole: 100 mg orally twice daily
|
|---|---|
|
Tumor Response as Measured by RECIST Criteria
Stable disease
|
6 Participants
|
|
Tumor Response as Measured by RECIST Criteria
Progressive disease
|
7 Participants
|
SECONDARY outcome
Timeframe: From date of randomization through completion of follow-up, up to three yearsAdverse events (AEs) were evaluated and graded using the National Cancer Institute Common Toxicity Criteria, version 3.0.
Outcome measures
| Measure |
Riluzole
n=13 Participants
100 mg orally twice daily
riluzole: 100 mg orally twice daily
|
|---|---|
|
Number of Participants With at Least One Adverse Event
|
9 Participants
|
SECONDARY outcome
Timeframe: Overall survival at one yearKaplan-Meier plots of probability of overall survival.
Outcome measures
| Measure |
Riluzole
n=13 Participants
100 mg orally twice daily
riluzole: 100 mg orally twice daily
|
|---|---|
|
Overall Survival
|
1 Participants
|
Adverse Events
Riluzole
Serious events: 10 serious events
Other events: 11 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Riluzole
n=13 participants at risk
100 mg orally twice daily
riluzole: 100 mg orally twice daily
|
|---|---|
|
General disorders
Dizziness
|
7.7%
1/13 • Number of events 2 • From date of randomization through completion of follow-up, up to three years
|
|
General disorders
Muscle weakness, generalized or specific area
|
15.4%
2/13 • Number of events 2 • From date of randomization through completion of follow-up, up to three years
|
|
General disorders
Death
|
7.7%
1/13 • Number of events 1 • From date of randomization through completion of follow-up, up to three years
|
|
Infections and infestations
Infection
|
7.7%
1/13 • Number of events 1 • From date of randomization through completion of follow-up, up to three years
|
|
General disorders
Dehydration
|
15.4%
2/13 • Number of events 2 • From date of randomization through completion of follow-up, up to three years
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
7.7%
1/13 • Number of events 1 • From date of randomization through completion of follow-up, up to three years
|
|
General disorders
Pain - Extremity-limb
|
7.7%
1/13 • Number of events 1 • From date of randomization through completion of follow-up, up to three years
|
|
Nervous system disorders
Neuropathy: motor
|
7.7%
1/13 • Number of events 1 • From date of randomization through completion of follow-up, up to three years
|
Other adverse events
| Measure |
Riluzole
n=13 participants at risk
100 mg orally twice daily
riluzole: 100 mg orally twice daily
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal
|
53.8%
7/13 • Number of events 11 • From date of randomization through completion of follow-up, up to three years
|
|
Gastrointestinal disorders
Constitutional Symptoms
|
61.5%
8/13 • Number of events 10 • From date of randomization through completion of follow-up, up to three years
|
|
Nervous system disorders
Neurology
|
53.8%
7/13 • Number of events 14 • From date of randomization through completion of follow-up, up to three years
|
|
General disorders
Pain
|
38.5%
5/13 • Number of events 7 • From date of randomization through completion of follow-up, up to three years
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory
|
23.1%
3/13 • Number of events 10 • From date of randomization through completion of follow-up, up to three years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue
|
23.1%
3/13 • Number of events 3 • From date of randomization through completion of follow-up, up to three years
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow
|
15.4%
2/13 • Number of events 2 • From date of randomization through completion of follow-up, up to three years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory
|
15.4%
2/13 • Number of events 2 • From date of randomization through completion of follow-up, up to three years
|
|
Cardiac disorders
Cardiac General
|
7.7%
1/13 • Number of events 1 • From date of randomization through completion of follow-up, up to three years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
7.7%
1/13 • Number of events 1 • From date of randomization through completion of follow-up, up to three years
|
|
Infections and infestations
Infection
|
7.7%
1/13 • Number of events 1 • From date of randomization through completion of follow-up, up to three years
|
|
Eye disorders
Ocular/Visual
|
7.7%
1/13 • Number of events 1 • From date of randomization through completion of follow-up, up to three years
|
Additional Information
James Goydos, MD
Rutgers Cancer Institute of New Jersey
Phone: (732) 235-7593
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place