Trial Outcomes & Findings for Study of Lenalidomide With Vorinostat in Pediatric Patients With High Grade or Progressive CNS Tumors (NCT NCT03050450)
NCT ID: NCT03050450
Last Updated: 2021-04-05
Results Overview
Collect and grade all of the adverse events to evaluate for safety. This data was collected for the first 2 cycles for each participant.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
Two 28 day cycles
Results posted on
2021-04-05
Participant Flow
2 participants were unable to start because they couldn't swallow pills. Study did not proceed beyond dose level 1.
Participant milestones
| Measure |
Dose Level 1
25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 25 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 2
50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 50 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 3
100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 100 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 4
150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 5
150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®)
150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 230 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
5
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Dose Level 1
25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 25 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 2
50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 50 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 3
100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 100 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 4
150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 5
150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®)
150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 230 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study of Lenalidomide With Vorinostat in Pediatric Patients With High Grade or Progressive CNS Tumors
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=6 Participants
25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 25 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 2
50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 50 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 3
100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 100 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 4
150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 5
150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®)
150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 230 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
7.1 years
n=5 Participants
|
—
|
—
|
—
|
—
|
7.1 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
4 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
5 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
6 Participants
n=8 Participants
|
|
Diagnosis
Low Grade Glioma
|
1 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
1 Participants
n=8 Participants
|
|
Diagnosis
High Grade Glioma
|
1 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
1 Participants
n=8 Participants
|
|
Diagnosis
ATRT
|
1 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
1 Participants
n=8 Participants
|
|
Diagnosis
Ependymoma
|
2 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
2 Participants
n=8 Participants
|
|
Diagnosis
DIPG
|
1 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Two 28 day cyclesPopulation: Did not go beyond dose level 1.
Collect and grade all of the adverse events to evaluate for safety. This data was collected for the first 2 cycles for each participant.
Outcome measures
| Measure |
Dose Level 1
n=6 Participants
25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 25 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 2
50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 50 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 3
100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 100 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 4
150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 5
150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®)
150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 230 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
|---|---|---|---|---|---|
|
Total Number of Adverse Events
Grade 1 adverse events
|
68 total adverse events
|
—
|
—
|
—
|
—
|
|
Total Number of Adverse Events
Grace 2 adverse events
|
32 total adverse events
|
—
|
—
|
—
|
—
|
|
Total Number of Adverse Events
Grade 3 adverse events
|
12 total adverse events
|
—
|
—
|
—
|
—
|
|
Total Number of Adverse Events
Grade 4 adverse events
|
2 total adverse events
|
—
|
—
|
—
|
—
|
|
Total Number of Adverse Events
Grade 5 adverse events
|
1 total adverse events
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 2 cycles up to 24 cyclesPopulation: Did not go beyond dose level 1. 4 participants were assessed for this outcome.
Best response by MRIs per definitions in the protocol (complete response, partial response, stable disease, progressive disease). MRI's were obtained every 2 cycles and the best response was reported.
Outcome measures
| Measure |
Dose Level 1
n=4 Participants
25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 25 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 2
50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 50 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 3
100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 100 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 4
150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 5
150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®)
150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 230 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
|---|---|---|---|---|---|
|
Best Response of Children With Recurrent or Refractory Central Nervous System Tumors
Complete Response
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Best Response of Children With Recurrent or Refractory Central Nervous System Tumors
Partial Response
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Best Response of Children With Recurrent or Refractory Central Nervous System Tumors
Stable Disease
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Best Response of Children With Recurrent or Refractory Central Nervous System Tumors
Progressive Disease
|
2 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 yearPopulation: Data was not collected for this outcome measure.
2 year actual event free survival with children treated with this protocol.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Two 28 day cyclesPopulation: Did not go beyond dose level 1.
Number participants with grades 3 to 5 hematologic and non-hematologic toxicities. All toxicities are for end of cycle 2.
Outcome measures
| Measure |
Dose Level 1
n=6 Participants
25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 25 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 2
50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 50 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 3
100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 100 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 4
150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 5
150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®)
150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 230 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
|---|---|---|---|---|---|
|
Number Participants With Hematologic and Non-hematologic Toxicities
Grade 3 & 4 Blood/Bone Marrow
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number Participants With Hematologic and Non-hematologic Toxicities
Grade 3 & 4 Gastrointestinal
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number Participants With Hematologic and Non-hematologic Toxicities
Grade 3 & 4 Metabolic/Laboratory
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number Participants With Hematologic and Non-hematologic Toxicities
Grade 3 & 4 Musculoskelatal/Soft Tissue
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number Participants With Hematologic and Non-hematologic Toxicities
Grade 3 & 4 Neurology
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number Participants With Hematologic and Non-hematologic Toxicities
Grade 3 & 4 Pain
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number Participants With Hematologic and Non-hematologic Toxicities
Grade 3 & 4 Vascular
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number Participants With Hematologic and Non-hematologic Toxicities
Grade 3 & 4 & 5 Other
|
6 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
Dose Level 1
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Level 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Level 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Level 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Level 5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1
n=6 participants at risk
25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 25 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 2
50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 50 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 3
100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 100 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 4
150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 5
150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®)
150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 230 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Hospitalized for ascites
|
16.7%
1/6 • Number of events 1 • Two 28 day cycles for each patient
did not go beyond dose level 1
|
—
0/0 • Two 28 day cycles for each patient
did not go beyond dose level 1
|
—
0/0 • Two 28 day cycles for each patient
did not go beyond dose level 1
|
—
0/0 • Two 28 day cycles for each patient
did not go beyond dose level 1
|
—
0/0 • Two 28 day cycles for each patient
did not go beyond dose level 1
|
|
Gastrointestinal disorders
Hospitalized for abdominal pain
|
16.7%
1/6 • Number of events 1 • Two 28 day cycles for each patient
did not go beyond dose level 1
|
—
0/0 • Two 28 day cycles for each patient
did not go beyond dose level 1
|
—
0/0 • Two 28 day cycles for each patient
did not go beyond dose level 1
|
—
0/0 • Two 28 day cycles for each patient
did not go beyond dose level 1
|
—
0/0 • Two 28 day cycles for each patient
did not go beyond dose level 1
|
Other adverse events
| Measure |
Dose Level 1
n=6 participants at risk
25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 25 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 2
50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 50 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 3
100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 100 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 4
150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
Dose Level 5
150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®)
150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®): Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 230 mg/m2 days 1-7 and 15-21 of a 28 day cycle
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Grade 3-4
|
33.3%
2/6 • Number of events 3 • Two 28 day cycles for each patient
did not go beyond dose level 1
|
—
0/0 • Two 28 day cycles for each patient
did not go beyond dose level 1
|
—
0/0 • Two 28 day cycles for each patient
did not go beyond dose level 1
|
—
0/0 • Two 28 day cycles for each patient
did not go beyond dose level 1
|
—
0/0 • Two 28 day cycles for each patient
did not go beyond dose level 1
|
Additional Information
Dr Stacie Stapleton
Johns Hopkins All Children's Hospital (St. Petersburg, FL)
Phone: 17274701017
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place