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
Status: Completed
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 21
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Childrens Hospital of Alabama
Birmingham
California
Children's Oncology Group
Monrovia
Childrens Hospital of Orange County
Orange
University of California, San Francisco
San Francisco
Washington, D.c.
Children's National Medical Center
Washington
Georgia
Children's Healthcare of Atlanta at Scottish Rite
Atlanta
Illinois
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago
Indiana
Riley Hospital for Children
Indianapolis
Maryland
Mark O Harfield-Warren Grant Magnuson Clinical Center
Bethesda
Michigan
University of Michigan Health Systems
Ann Arbor
Minnesota
University of Minnesota Hospital
Minneapolis
Missouri
Washington University Medical School
Saint Louis
New York
Columbia University Medical Center
New York
Ohio
Children's Hospital Medical Center
Cincinnati
Oregon
Oregon Health and Science University
Portland
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
Childrens Hospital of Pittsburgh
Pittsburgh
Tennessee
St Jude Childrens Research Hospital
Memphis
Texas
Texas Childrens Hospital
Houston
Washington
Seattle Children's Hospital Research Foundation
Seattle
Wisconsin
Medical College of Wisconsin
Milwaukee
Time Frame
Start Date: 2015-12-11
Completion Date: 2019-07-16
Participants
Target number of participants: 29
Treatments
Experimental: Ramucirumab
(Part A-Non-CNS Solid Tumors) Escalating doses of 8 milligrams per kilogram (mg/kg) or 12 mg/kg Ramucirumab administered as an intravenous infusion every 2 weeks (Q2W) with 3 doses per 42 day cycle.~(Part B-CNS Tumors) Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
Authors
Thomas W Cash, Jodi Muscal, Kieuhoa Vo, Josephine HaDuong, Cynthia Wetmore, Gregory Friedman, Rajen Mody, Ivan Kirov, Brigitte Widemann, Suman Malempati, Emily Greengard, Jason Fangusaro, Jean M Tersak, Robert Hayashi, James Croop, Katherine Matthay, Stewart Goldman, Wayne Furman, Paul Harker-Murray, AeRang Kim, James Geller, Alyssa Reddy
Sponsors
Collaborators: Children's Oncology Group
Leads: Eli Lilly and Company