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Vilon

KE, L-Lys-L-Glu, lysylglutamic acid

Quick Stats
Studies 40
Trials 100
Completed PHASE2 INTERVENTIONAL NCT00679354

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

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

Primary Outcomes

Measure: Objective Response to Cilengitide
TimeFrame: Up to 16 weeks
Description: Objective response is defined as a complete response or partial response at 4 weeks that is sustained for at least another 4 weeks, or a stable disease at 4 weeks that is sustained for at least 12 weeks while on stable or decreasing dose of corticosteroids, except when corticosteroids are being used to control hydrocephaly unrelated to tumor progression.

Trial Information

NCT ID

NCT00679354

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

National Cancer Institute (NCI)

Last Updated

December 15, 2025