Why are we doing this research?
The main purpose of this study is to evaluate the safety of the study drug known as ramucirumab in children with recurrent or refractory solid tumors including central nervous system (CNS) tumors.
Primary Outcome Measures:
- Maximum Tolerated Dose of Ramucirumab [ Time Frame: Baseline to Study Completion (Approximately 42 Months) ] [ Designated as safety issue: No ]
- Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab [ Time Frame: Predose Cycle 1 Day 1 through Follow-Up (Approximately 6 Months) ] [ Designated as safety issue: No ]
- Number of Participants with Anti-Ramucirumab Antibodies [ Time Frame: Predose Cycle 1 Day 1 through Follow-Up (Approximately 42 Months) ] [ Designated as safety issue: No ]
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Who can participate?
AGES ELIGIBLE FOR STUDY: 12 Months to 21 Years
- Part A: participants with recurrent or refractory non-CNS solid tumors
- Part B: participants with recurrent or refractory CNS tumors
- Measurable or evaluable disease
- No other therapeutic options
- Performance Status: Karnofsky ≥50% for participants >16 years and Lansky ≥50 for participants ≤16 years
- Active or recent history of serious bleeding events
- Active or recent history of gastrointestinal perforations, ulcers, fistulas or abscesses
- Active or recent history of hypertensive crisis or hypertensive encephalopathy
- Active non-healing wound or bone fracture
- History of solid organ transplant