Trial Outcomes & Findings for Lenalidomide, Sunitinib, and Cyclophosphamide in Treating Patients With Stage IV Eye Melanoma (NCT NCT00482911)
NCT ID: NCT00482911
Last Updated: 2017-03-27
Results Overview
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
2 years
Results posted on
2017-03-27
Participant Flow
Participant milestones
| Measure |
Cohort 1-lenalidomide & Cyclophosphamide
Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
|
Cohort 2-sunitinib & Cyclophosphamide
2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
|
|---|---|---|
|
Dosing Schedule 1: Len & Cyc
STARTED
|
3
|
0
|
|
Dosing Schedule 1: Len & Cyc
COMPLETED
|
3
|
0
|
|
Dosing Schedule 1: Len & Cyc
NOT COMPLETED
|
0
|
0
|
|
Dosing Schedule 1: Len, Cyc, & Sun
STARTED
|
3
|
2
|
|
Dosing Schedule 1: Len, Cyc, & Sun
COMPLETED
|
3
|
2
|
|
Dosing Schedule 1: Len, Cyc, & Sun
NOT COMPLETED
|
0
|
0
|
|
Dosing Schedule 2: Len, Cyc, & Sun
STARTED
|
0
|
7
|
|
Dosing Schedule 2: Len, Cyc, & Sun
COMPLETED
|
0
|
7
|
|
Dosing Schedule 2: Len, Cyc, & Sun
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide, Sunitinib, and Cyclophosphamide in Treating Patients With Stage IV Eye Melanoma
Baseline characteristics by cohort
| Measure |
Cohort 1-lenalidomide & Cyclophosphamide
n=3 Participants
Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
|
Cohort 2-sunitinib & Cyclophosphamide
n=9 Participants
2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
|
Total
n=12 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
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 15.52 • n=5 Participants
|
54.89 years
STANDARD_DEVIATION 6.44 • n=7 Participants
|
57.27 years
STANDARD_DEVIATION 9.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 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
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 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
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Cohort 2 = 9 patients. Two patients received Dose B-QD in cycle 1 as outlined in participant flow. Seven patients received Dose D-QD in cycle 1 as outlined in participant flow.
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Cohort 1-lenalidomide & Cyclophosphamide
n=3 Participants
Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
|
Cohort 2-sunitinib & Cyclophosphamide
n=9 Participants
2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
|
|---|---|---|
|
Response Rate (Complete and Partial Response)
Complete Response
|
0 Participants
|
0 Participants
|
|
Response Rate (Complete and Partial Response)
Partial Response
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 16 monthsPopulation: Cohort 2 = 9 patients. Two patients received Dose B-QD in cycle 1 as outlined in participant flow. Seven patients received Dose D-QD in cycle 1 as outlined in participant flow.
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Cohort 1-lenalidomide & Cyclophosphamide
n=3 Participants
Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
|
Cohort 2-sunitinib & Cyclophosphamide
n=9 Participants
2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
|
|---|---|---|
|
Toxicity
|
3 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: up to 16 monthsPopulation: Overall survival is not the same as response, to obtain overall survival the investigator would have to follow patients until death, which the original investigator left the institution well before this outcome could be accomplished.
Time from 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: up to 16 monthsPopulation: Overall survival is not the same as response, to obtain overall survival the investigator would have to follow patients until death, which the original investigator left the institution well before this outcome could be accomplished
Proportion of patients who progress or die after the start of treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and end of treatment course 1 and 2, approximately 42 daysPopulation: Overall survival is not the same as response, to obtain overall survival the investigator would have to follow patients until death, which the original investigator left the institution well before this outcome could be accomplished
Ribonucleic acid (RNA), deoxyribonucleic acid (DNA) and protein obtained from blood, urine and/or tissue was to be evaluated for changes in gene expression, methylation and/or protein modification.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1-lenalidomide & Cyclophosphamide
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2-sunitinib & Cyclophosphamide
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1-lenalidomide & Cyclophosphamide
n=3 participants at risk
Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
|
Cohort 2-sunitinib & Cyclophosphamide
n=9 participants at risk
2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
|
|---|---|---|
|
Infections and infestations
Infection
|
0.00%
0/3 • 16 months
|
11.1%
1/9 • Number of events 1 • 16 months
|
|
Investigations
Leukocytes (total WBC)
|
0.00%
0/3 • 16 months
|
11.1%
1/9 • Number of events 1 • 16 months
|
|
Investigations
Neutrophils/granulocytes (ANC/AG)
|
0.00%
0/3 • 16 months
|
11.1%
1/9 • Number of events 1 • 16 months
|
|
Gastrointestinal disorders
Obstruction, GI: cecum
|
0.00%
0/3 • 16 months
|
11.1%
1/9 • Number of events 1 • 16 months
|
Other adverse events
| Measure |
Cohort 1-lenalidomide & Cyclophosphamide
n=3 participants at risk
Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
|
Cohort 2-sunitinib & Cyclophosphamide
n=9 participants at risk
2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
|
|---|---|---|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
33.3%
1/3 • Number of events 1 • 16 months
|
11.1%
1/9 • Number of events 1 • 16 months
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 2 • 16 months
|
44.4%
4/9 • Number of events 11 • 16 months
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 2 • 16 months
|
44.4%
4/9 • Number of events 7 • 16 months
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
33.3%
1/3 • Number of events 1 • 16 months
|
11.1%
1/9 • Number of events 1 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
33.3%
1/3 • Number of events 1 • 16 months
|
11.1%
1/9 • Number of events 1 • 16 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
66.7%
2/3 • Number of events 3 • 16 months
|
22.2%
2/9 • Number of events 3 • 16 months
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
33.3%
1/3 • Number of events 1 • 16 months
|
22.2%
2/9 • Number of events 2 • 16 months
|
|
Injury, poisoning and procedural complications
Fracture
|
33.3%
1/3 • Number of events 1 • 16 months
|
0.00%
0/9 • 16 months
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
33.3%
1/3 • Number of events 1 • 16 months
|
0.00%
0/9 • 16 months
|
|
Gastrointestinal disorders
hemorrhoids
|
33.3%
1/3 • Number of events 1 • 16 months
|
0.00%
0/9 • 16 months
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
33.3%
1/3 • Number of events 1 • 16 months
|
0.00%
0/9 • 16 months
|
|
Investigations
Leukocytes (total WBC)
|
100.0%
3/3 • Number of events 7 • 16 months
|
66.7%
6/9 • Number of events 11 • 16 months
|
|
Investigations
Lymphopenia
|
33.3%
1/3 • Number of events 1 • 16 months
|
22.2%
2/9 • Number of events 2 • 16 months
|
|
Psychiatric disorders
Mood alteration::Depression
|
33.3%
1/3 • Number of events 1 • 16 months
|
0.00%
0/9 • 16 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Oral cavity
|
33.3%
1/3 • Number of events 1 • 16 months
|
11.1%
1/9 • Number of events 2 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
33.3%
1/3 • Number of events 1 • 16 months
|
0.00%
0/9 • 16 months
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • 16 months
|
22.2%
2/9 • Number of events 2 • 16 months
|
|
Investigations
Neutrophils/granulocytes (ANC/AG)
|
100.0%
3/3 • Number of events 9 • 16 months
|
77.8%
7/9 • Number of events 16 • 16 months
|
|
Gastrointestinal disorders
Pain: Abdomen NOS
|
33.3%
1/3 • Number of events 1 • 16 months
|
44.4%
4/9 • Number of events 5 • 16 months
|
|
Nervous system disorders
Pain::Head/headache
|
33.3%
1/3 • Number of events 1 • 16 months
|
0.00%
0/9 • 16 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Joint
|
33.3%
1/3 • Number of events 1 • 16 months
|
11.1%
1/9 • Number of events 1 • 16 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Muscle
|
33.3%
1/3 • Number of events 1 • 16 months
|
33.3%
3/9 • Number of events 4 • 16 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Neck
|
33.3%
1/3 • Number of events 1 • 16 months
|
0.00%
0/9 • 16 months
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
33.3%
1/3 • Number of events 1 • 16 months
|
0.00%
0/9 • 16 months
|
|
Eye disorders
Photosensitivity
|
33.3%
1/3 • Number of events 1 • 16 months
|
0.00%
0/9 • 16 months
|
|
Investigations
Platelets
|
33.3%
1/3 • Number of events 1 • 16 months
|
0.00%
0/9 • 16 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
66.7%
2/3 • Number of events 4 • 16 months
|
33.3%
3/9 • Number of events 4 • 16 months
|
|
General disorders
Rigors/chills
|
66.7%
2/3 • Number of events 3 • 16 months
|
0.00%
0/9 • 16 months
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
33.3%
1/3 • Number of events 1 • 16 months
|
11.1%
1/9 • Number of events 1 • 16 months
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
66.7%
2/3 • Number of events 2 • 16 months
|
33.3%
3/9 • Number of events 4 • 16 months
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • 16 months
|
0.00%
0/9 • 16 months
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/3 • 16 months
|
22.2%
2/9 • Number of events 2 • 16 months
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
0.00%
0/3 • 16 months
|
22.2%
2/9 • Number of events 2 • 16 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • 16 months
|
33.3%
3/9 • Number of events 3 • 16 months
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
0.00%
0/3 • 16 months
|
11.1%
1/9 • Number of events 1 • 16 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • 16 months
|
11.1%
1/9 • Number of events 1 • 16 months
|
|
General disorders
Edema: limb
|
0.00%
0/3 • 16 months
|
11.1%
1/9 • Number of events 1 • 16 months
|
|
Gastrointestinal disorders
Hemorrhage, GI::Rectum
|
0.00%
0/3 • 16 months
|
11.1%
1/9 • Number of events 1 • 16 months
|
|
Infections and infestations
Infection
|
0.00%
0/3 • 16 months
|
11.1%
1/9 • Number of events 1 • 16 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
|
0.00%
0/3 • 16 months
|
11.1%
1/9 • Number of events 1 • 16 months
|
|
Gastrointestinal disorders
Pain::Oral cavity
|
0.00%
0/3 • 16 months
|
11.1%
1/9 • Number of events 1 • 16 months
|
|
Gastrointestinal disorders
Pain::Oral gums
|
0.00%
0/3 • 16 months
|
11.1%
1/9 • Number of events 1 • 16 months
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/3 • 16 months
|
11.1%
1/9 • Number of events 1 • 16 months
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
33.3%
1/3 • Number of events 1 • 16 months
|
22.2%
2/9 • Number of events 2 • 16 months
|
Additional Information
Steven A. Rosenberg, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-435-7507
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place