Clinical Trial: Cilengitide in Treating Children With Refractory Primary Brain Tumors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase I Study of Cilengitide (EMD 121974) in Children With Refractory Brain Tumors

Brief Summary: This phase I trial is studying the side effects and best dose of cilengitide in treating children with recurrent, progressive, or refractory primary CNS tumors. Cilengitide may slow the growth of brain cancer cells by stopping blood flow to the tumor.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To describe the acute and dose-limiting toxicities (DLT) and define the maximum tolerated dose (MTD) of cilengitide (EMD 121974) when administered to children and adolescents with refractory primary brain tumors.

SECONDARY OBJECTIVES:

I. To obtain preliminary evidence of biologic activity by determining alterations in tissue perfusion, tumor blood flow and metabolic activity using MR perfusion, PET and MRS and correlating these findings with changes in tumor size by volumetric MRI.

II. To characterize inter- and intra-patient variability in the pharmacokinetics of cilengitide and to estimate cilengitide renal clearance in this patient population.

III. To characterize the pharmacogenetic polymorphisms in drug transporters (e.g., MRP4, BCRP) and relate to cilengitide disposition.

IV. To evaluate changes in circulating endothelial cells (CECs) and circulating endothelial precursors (CEPs) in patients treated with cilengitide, and to investigate the correlation between changes in CECs and CEPs, plasma, serum and urine angiogenic protein levels such as VEGF, and clinical outcome.

V. To obtain preliminary information about the efficacy of cilengitide in this patient population.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive cilengitide (EMD 121974) IV over 1 hour twice weekly. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity.

Coh
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: MTD of cilengitide [ Time Frame: 4 weeks ]

Original Primary Outcome:

Current Secondary Outcome: Response [ Time Frame: Up to 3 months ]

Reported and recorded descriptively.


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: July 8, 2003
Date Started: July 2003
Date Completion:
Last Updated: September 27, 2013
Last Verified: September 2013