ADVL1416: A Phase 1 Study of Ramucirumab, a Human Monoclonal Antibody Against the Vascular Endothelial Growth Factor-2 (VEGFR-2) Receptor in Children With Refractory Solid Tumors, Including CNS Tumors

Why are we doing this research?

PURPOSE:

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.

DETAILED DESCRIPTION:

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

ELIGIBILITY CRITERIA

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Conditions

  • Brain Spinal Tumors Medulloblastoma Relapse
  • Brain Spinal Tumor Low Grade Glioma Relapse
  • Brain Spinal Tumor DIPG Relapse
  • Brain and Spinal Tumor Ependymoma Relapse
  • Brain Spinal Neurofibromatosis Sarcoma MPNST Relapse
  • Brain Spinal Neurofibromatosis OPG
  • Sarcoma Ewing Relapse
  • Sarcoma Osteosarcoma Relapse
  • Sarcoma Rhabdomyosarcoma Relapse
  • Brain Spinal Other All Other
  • Brain Spinal Other ATRT
  • Brain Spinal Other Craniopharyngioma
  • Brain Spinal Other Germ Cell Tumor
  • Brain Spinal Other Choroid Plexus Tumor
  • Neuroblastoma Relapse - Refractory
  • Liver Relapse - Refractory
  • Kidney Relapse - Refractory
  • Solid Tumor Retinoblastoma Relapse - Refractory
  • Solid Tumor Neurofibromatosis Sarcoma MPNST Relapse - Refractory
  • Solid Tumor Neurofibromatosis OPG Low Grade Glioma
  • Solid Tumor Melanoma Relapse - Refractory
  • Solid Tumor Germ Cell Tumor Relapse - Refractory
  • Solid Tumors - All Other
  • Adult - Brain Spinal Tumors Medulloblastoma Relapse
  • Adult - Brain Spinal Tumor Low Grade Glioma Relapse
  • Adult - Brain Spinal Tumor DIPG Relapse
  • Adult - Brain and Spinal Tumor Ependymoma Relapse
  • Adult - Brain Spinal Neurofibromatosis Sarcoma MPNST Relapse
  • Adult - Brain Spinal Neurofibromatosis OPG
  • Adult - Brain Spinal Other All Other
  • Adult - Brain Spinal Other ATRT
  • Adult - Brain Spinal Other Choroid Plexus Tumor
  • Adult - Brain Spinal Other Craniopharyngioma
  • Adult - Brain Spinal Other Germ Cell Tumor
  • Adult - Sarcoma Osteosarcoma Relapse
  • Adult - Sarcoma Rhabdomyosarcoma Relapse
  • Adult - Sarcoma Ewing Relapse
  • Adult - Neuroblastoma Relapse - Refractory
  • Adult - Liver Relapse - Refractory
  • Adult - Kidney Relapse - Refractory
  • Adult - Solid Tumors - All Other
  • Adult - Solid Tumor Retinoblastoma Relapse - Refractory
  • Adult - Solid Tumor Neurofibromatosis Sarcoma MPNST Relapse - Refractory
  • Adult - Solid Tumor Neurofibromatosis OPG Low Grade Glioma
  • Adult - Solid Tumor Melanoma Relapse - Refractory
  • Adult - Solid Tumor Germ Cell Tumor Relapse - Refractory

Contact

Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799
cancer@cchmc.org