NCT00679354

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

Cilengitide (EMD 121974) (IND# 59073) in Recurrent or Progressive and Refractory Childhood High-Grade Glioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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 these patients. III. To evaluate the pharmacokinetics of cilengitide in plasma using a limited sampling strategy. IV. To evaluate the pharmacogenetic polymorphisms in drug transporters (eg, breast cancer resistance protein \[BCRP\], P-glycoprotein \[P-gp\]) and relate to cilengitide disposition. OUTLINE: 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 treatment, patients are followed up every 3 months for 2 years and then periodically for 3 years.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	cilengitide	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-10-01
• Completion: 2011-07-01
• First posted: 2008-05-16
• Last updated: 2018-08-01
• Results posted: 2014-02-20

Locations

20 sites across 2 countries: United States, Canada