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