Solid Tumor Treatment with Ramucirumab – Phase I

A Study of Ramucirumab, a Human Monoclonal Antibody Against the Vascular Endothelial Growth Factor-2 Receptor in Children with Refractory Solid Tumors, Including CNS Tumors

Protocol Description

Through this multicenter research study by the Children’s Oncology Group, researchers are evaluating the drug ramucirumab to fight recurrent tumors and tumors that will not respond to standard therapy. Ramucirumab, monoclonal antibody, has demonstrated potential through laboratory tests and has been used in adults, but not children. As a Phase I trial, this program evaluates the effects of the drug on tumors, as well as its side effects and how it is processed by the body, while researchers also evaluate proper dosage levels.

Study Level: Phase I

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to pediatric patients of both genders, from 12 months to 21 years of age, who have recurrent or refractory solid tumors.
Boys and girls: 12 months to 21 years old.


This study has two parts. Part A of this study involves patients with solid tumors that are not part of the central nervous system (CNS) and Part B involves patients with CNS tumors. In Part A, participants will receive escalating doses of ramucirumab intravenously every other week over a 6-week cycle. For Part B participants, the maximum tolerated dose and/or recommended dose, as determined from Part A, will be given every other week over a 6-week cycle. Participants in both study parts may continue treatment until discontinuation criteria are met. The first cycle of each part requires 13 visits for physical exams, treatment, blood work and imaging, and subsequent cycles require 8 visits.
Visits: 8 per 6-week cycle
Duration: Up to 1 year (8 cycles), depending on outcomes

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ADVL1416)
National Cancer Institute
Eli Lilly and Company

Primary Investigator

Jean Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Research Coordinator Angela Connelly, RN, BSN