Trial Outcomes & Findings for Lenalidomide (Revlimid) to Treat Advanced Ocular Melanoma (NCT NCT00109005)
NCT ID: NCT00109005
Last Updated: 2017-01-02
Results Overview
Clinical response is assessed by the Response Evaluation Criteria for Adverse Events in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
COMPLETED
PHASE2
17 participants
12 months
2017-01-02
Participant Flow
Participant milestones
| Measure |
Cohort 1 - 25 mg Lenalidomide (Revlimid)
oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
|
Cohort 2 - 5 mg Lenalidomide (Revlimid)
oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide (Revlimid) to Treat Advanced Ocular Melanoma
Baseline characteristics by cohort
| Measure |
Cohort 1 - 25 mg Lenalidomide (Revlimid)
n=8 Participants
oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
|
Cohort 2 - 5 mg Lenalidomide (Revlimid)
n=9 Participants
oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
58.86 years
STANDARD_DEVIATION 9.83 • n=7 Participants
|
55.56 years
STANDARD_DEVIATION 9.71 • n=5 Participants
|
|
Gender
Female
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Gender
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Response data was combined for this outcome measure. Results are available for the combined cohorts only. Sixteen out of seventeen patients were eligible for response assessments.
Clinical response is assessed by the Response Evaluation Criteria for Adverse Events in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)
n=16 Participants
oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
|
Cohort 2 - 5 mg Lenalidomide (Revlimid)
oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
|
|---|---|---|
|
Clinical Responses in Patients With Metastatic Ocular Melanoma
Complete Response
|
0 Participants
|
—
|
|
Clinical Responses in Patients With Metastatic Ocular Melanoma
Partial Response
|
0 Participants
|
—
|
|
Clinical Responses in Patients With Metastatic Ocular Melanoma
Progressive Disease
|
9 Participants
|
—
|
|
Clinical Responses in Patients With Metastatic Ocular Melanoma
Stable Disease
|
7 Participants
|
—
|
PRIMARY outcome
Timeframe: 24 monthsHere is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)
n=8 Participants
oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
|
Cohort 2 - 5 mg Lenalidomide (Revlimid)
n=9 Participants
oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
|
|---|---|---|
|
Number of Participants With Adverse Events
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: This outcome measure was not analyzed because the investigator left the institution.
Time interval from start of treatment to documented evidence of disease progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: This outcome measure was not analyzed because the investigator left the institution.
Date of on-study to the date of death from any cause or last follow up.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to treatment on cycle 1, day 1 and then on cycle 1, day 1 at 0.25, 0.5, 1, 2, 4, 6, 9 and 12 hours. Cycle 1, day 2 at 24 hours.Population: This outcome measure was not analyzed because the investigator left the institution.
Plasma samples will be obtained and plasma concentrations will be determined by a reversed-phase high-performance liquid chromatography (HPLC) assay using mass spectrometry (MS) detection.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: This outcome measure was not analyzed because the investigator left the institution.
The most efficacious dose (with greater number of responses) with acceptable toxicity profile will be considered for use in subsequent trials. iI the number of responses is tied, then toxicity criteria (Common Terminology criteria (CTC) v3.0) will be used to select the preferred dose.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and at the end of treatment cycles 3 and 6. Every 21 day supply of lenalidomide with a 7 day rest (total of 28 days) will be considered a cycle of therapy.Population: This outcome measure was not analyzed because the investigator left the institution.
Tissue will be obtained to evaluate the effects of lenalidomide on pathways thought to be modulated by lenalidomide.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1 - 25 mg Lenalidomide (Revlimid)
Cohort 2 - 5 mg Lenalidomide (Revlimid)
Serious adverse events
| Measure |
Cohort 1 - 25 mg Lenalidomide (Revlimid)
n=8 participants at risk
oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
|
Cohort 2 - 5 mg Lenalidomide (Revlimid)
n=9 participants at risk
oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Colitis
|
12.5%
1/8 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Death not associated with CTCAE term: Death Progression NOS
|
12.5%
1/8 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
Other adverse events
| Measure |
Cohort 1 - 25 mg Lenalidomide (Revlimid)
n=8 participants at risk
oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
|
Cohort 2 - 5 mg Lenalidomide (Revlimid)
n=9 participants at risk
oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
|
|---|---|---|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
12.5%
1/8 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
25.0%
2/8 • Number of events 2
|
22.2%
2/9 • Number of events 3
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
|
Investigations
Alkaline phosphatase
|
12.5%
1/8 • Number of events 3
|
33.3%
3/9 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 4
|
22.2%
2/9 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
2/8 • Number of events 4
|
0.00%
0/9
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
87.5%
7/8 • Number of events 14
|
33.3%
3/9 • Number of events 9
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
25.0%
2/8 • Number of events 2
|
22.2%
2/9 • Number of events 5
|
|
General disorders
Flu-like symptoms
|
12.5%
1/8 • Number of events 4
|
0.00%
0/9
|
|
Investigations
Hemoglobin
|
37.5%
3/8 • Number of events 4
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC::Lung (pneumonia)
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
|
Infections and infestations
Infection with unknown ANC::(Sinus)
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft tissue - Other (Specify, tingling of hands and R foot)
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
|
Gastrointestinal disorders
Nausea
|
62.5%
5/8 • Number of events 16
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
12.5%
1/8 • Number of events 3
|
11.1%
1/9 • Number of events 2
|
|
Nervous system disorders
Pain::Head/headache
|
25.0%
2/8 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain::Muscle
|
25.0%
2/8 • Number of events 2
|
0.00%
0/9
|
|
Gastrointestinal disorders
Pain::Oral gums
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
12.5%
1/8 • Number of events 1
|
22.2%
2/9 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
12.5%
1/8 • Number of events 3
|
22.2%
2/9 • Number of events 2
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
|
Eye disorders
Vision-flashing lights/floaters
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Creatinine
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
|
Vascular disorders
hematoma
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
|
Investigations
INR (International Normalized Ratio of prothrombin time)
|
0.00%
0/8
|
11.1%
1/9 • Number of events 2
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
25.0%
2/8 • Number of events 2
|
11.1%
1/9 • Number of events 2
|
|
Investigations
Leukocytes (total WBC)
|
0.00%
0/8
|
11.1%
1/9 • Number of events 3
|
|
Investigations
Lymphopenia
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
|
Psychiatric disorders
Mood alteration::Depression
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain: Back
|
0.00%
0/8
|
11.1%
1/9 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain: Extremity-limb
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain::Joint
|
0.00%
0/8
|
11.1%
1/9 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
0.00%
0/8
|
11.1%
1/9 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8
|
22.2%
2/9 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
12.5%
1/8 • Number of events 5
|
0.00%
0/9
|
Additional Information
Caryn Steakley
National Cancer Institute, National Institutes of Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place