Cilengitide in Treating Younger Patients With Recurrent or Progressive High-Grade Glioma That Has Not Responded to Standard Therapy

Completed · Phase 2

Conditions studied: Childhood High-grade Cerebellar Astrocytoma, Childhood High-grade Cerebral Astrocytoma, Recurrent Childhood Anaplastic Astrocytoma, Recurrent Childhood Anaplastic Oligoastrocytoma, Recurrent Childhood Anaplastic Oligodendroglioma, Recurrent Childhood Brain Tumor, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Glioblastoma, Recurrent Childhood Visual Pathway and Hypothalamic Glioma

In brief

This phase II trial studies how well cilengitide works in treating younger patients with recurrent or progressive high-grade glioma that has not responded to standard therapy. Cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor.

Key facts

Study ID

NCT00679354

Run by

National Cancer Institute (NCI)

People needed

30

Starts

2008-06-01

Expected to finish

2011-07-01

Last updated by the study team

2018-08-01

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed primary central nervous system (CNS) high-grade glioma, including any of the following:
• Glioblastoma multiforme
• Anaplastic astrocytoma
• Anaplastic oligodendroglioma
• High-grade astrocytoma not otherwise specified (i.e., anaplastic ganglioglioma, anaplastic mixed glioma, or anaplastic mixed glioneuronal tumors)
• No diffuse pontine gliomas, gliomatosis cerebri, and primary spinal cord high-grade astrocytoma
• Gliosarcoma
• Recurrent or progressive disease that is refractory to standard therapy
• Radiographically documented measurable disease
• Lesion must be at least twice the thickness of the image from which it is derived (e.g., 10 mm for a 5 mm slice thickness)
• No diffuse pontine gliomas
• No evidence of prior CNS bleeding
• Karnofsky performance status (PS) 50-100% (patients > 16 years of age)
• Lansky PS 50-100% (patients =< 16 years of age)
• Life expectancy >= 8 weeks
• Absolute neutrophil count (ANC) >= 1,000/μL
• Platelet count >= 100,000/μL (transfusion independent)
• Hemoglobin >= 8.0 g/dL (red blood cell [RBC] transfusions allowed)
• Creatinine clearance or radioisotope glomerular filtration rate >= 70mL/min OR serum creatinine based on age/gender as follows:
• 0.4 mg/dL (1 month to < 6 months of age)
• 0.5 mg/dL (6 months to < 1 year of age)
• 0.6 mg/dL (1 to < 2 years of age)
• 0.8 mg/dL (2 to < 6 years of age)
• 1.0 mg/dL (6 to < 10 years of age)
• 1.2 mg/dL (10 to < 13 years of age)

Where it is running

• Kaiser Permanente-Oakland — Oakland, California, United States
• University of California San Francisco Medical Center-Parnassus — San Francisco, California, United States
• Lombardi Comprehensive Cancer Center at Georgetown University — Washington D.C., District of Columbia, United States
• Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Wayne State University/Karmanos Cancer Institute — Detroit, Michigan, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• New York University Langone Medical Center — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Children's Hospital Medical Center of Akron — Akron, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Palmetto Health Richland — Columbia, South Carolina, United States
• T C Thompson Children's Hospital — Chattanooga, Tennessee, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Midwest Children's Cancer Center — Milwaukee, Wisconsin, United States
• CancerCare Manitoba — Winnipeg, Manitoba, Canada

Full record on ClinicalTrials.gov

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