Cilengitide (EMD 121974) (IND# 59073) in Recurrent or Progressive and Refractory Childhood High-Grade Glioma
I. To determine the objective response rate to cilengitide in younger patients with
recurrent or progressive high-grade glioma that is refractory to standard therapy.
I. To estimate the distribution of time to progression, time to treatment failure, and time
to death in these patients.
II. To estimate the rate of toxicity, especially symptomatic intratumoral hemorrhage, in
III. To evaluate the pharmacokinetics of Cilengitide in plasma using a limited sampling
IV. To evaluate the pharmacogenetic polymorphisms in drug transporters (eg, BCRP, P-gp) and
relate to Cilengitide disposition.
OUTLINE: This is a multicenter study.
Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months for 2 years and then
periodically for 3 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate to cilengitide
Objective response is defined as defined as complete response or partial response that is sustained for at least 4 weeks, or stable disease that is sustained for at least 12 weeks while on stable or decreasing dose of corticosteroids. The study will employ a two stage rule. Objective response rate among study participants will be estimated as a simple binomial proportion. The exact 95% confidence interval for objective response rate will be calculated.
Up to 5 years
Children's Oncology Group
United States: Food and Drug Administration
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|Midwest Children's Cancer Center||Milwaukee, Wisconsin 53226|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Newark Beth Israel Medical Center||Newark, New Jersey 07112|
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|
|Children's Hospital Medical Center of Akron||Akron, Ohio 44308|
|Montefiore Medical Center||Bronx, New York 10467-2490|
|Nationwide Children's Hospital||Columbus, Ohio 43205-2696|
|Wayne State University||Detroit, Michigan 48202|
|Oregon Health and Science University||Portland, Oregon 97201|
|Seattle Children's Hospital||Seattle, Washington 98105|
|Wake Forest University Health Sciences||Winston-Salem, North Carolina 27157|
|Childrens Memorial Hospital||Chicago, Illinois 60614|
|Kaiser Permanente-Oakland||Oakland, California 94611|
|Lombardi Comprehensive Cancer Center at Georgetown University||Washington, District of Columbia 20057|
|New York University Langone Medical Center||New York, New York 10016|
|University of California San Francisco Medical Center||San Francisco, California 94143|
|Palmetto Health Richland||Columbia, South Carolina 29203|
|T C Thompson Children's Hospital||Chattanooga, Tennessee 37403|