Study of Lenalidomide With Vorinostat in Pediatric Patients With High Grade or Progressive CNS Tumors
Part of paid clinical trials in St. Petersburg, Florida.
- Sponsor
- Johns Hopkins All Children's Hospital
- Study ID
- NCT03050450
- Phase
- PHASE1
- Status
- Terminated
Conditions
- Central Nervous System Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Year - 21 Years
- Healthy Volunteers
- Not accepted
Interventions
- 25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®) — DRUGDrug: 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
- 50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®) — DRUGDrug: 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
- 100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®) — DRUGDrug: 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
- 150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®) — DRUGDrug: 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
- 150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®) — DRUGDrug: 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
Study Details
Independently, both lenalidomide and vorinostat have shown promising activity in pediatric central nervous system (CNS) tumors. These are both agents that are not typically part of first-line studies, although both agents are of serious interest and are currently in clinical trials for further investigation. This study is to evaluate the combination of lenalidomide and vorinostat in high grade or progressive central nervous system tumors in children.
Key Dates
- Start date
- Aug 10, 2016
- Status verified
- Mar 2021
- Primary completion
- Dec 19, 2018
- Completion
- Dec 19, 2018
Study Design
- Enrollment
- 8 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: dose level 125 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
- Experimental: dose level 250 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
- Experimental: dose level 3100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
- Experimental: dose level 4150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)
- Experimental: dose level 5150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®)
Primary Outcome Measure
Total Number of Adverse Events [ Time Frame: Two 28 day cycles ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Johns Hopkins All Childen's Hospital | St. Petersburg | Florida | 33701 | - |
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