Cilengitide in Treating Younger Patients With Recurrent or Progressive High-Grade Glioma That Has Not Responded to Standard Therapy
This phase II trial is studying 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
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 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, 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
Childhood High-grade Cerebellar Astrocytoma
cilengitide, laboratory biomarker analysis, pharmacological study
National Cancer Institute (NCI)
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT01648400
- Information obtained from ClinicalTrials.gov on August 02, 2012
Medical and Biotech [MESH] Definitions
A type of analysis in which subjects in a study group and a comparison group are made comparable with respect to extraneous factors by individually pairing study subjects with the comparison group subjects (e.g., age-matched controls).
Costs And Cost Analysis
Absolute, comparative, or differential costs pertaining to services, institutions, resources, etc., or the analysis and study of these costs.
A set of techniques used when variation in several variables has to be studied simultaneously. In statistics, multivariate analysis is interpreted as any analytic method that allows simultaneous study of two or more dependent variables.
Proportional Hazards Models
Statistical models used in survival analysis that assert that the effect of the study factors on the hazard rate in the study population is multiplicative and does not change over time.
Body of knowledge related to the use of organisms, cells or cell-derived constituents for the purpose of developing products which are technically, scientifically and clinically useful. Alteration of biologic function at the molecular level (i.e., GENETIC ENGINEERING) is a central focus; laboratory methods used include TRANSFECTION and CLONING technologies, sequence and structure analysis algorithms, computer databases, and gene and protein structure function analysis and prediction.
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