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Cilengitide in Combination With Irradiation in Children With Diffuse Intrinsic Pontine Glioma

NCT01165333 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-03-16

No results posted yet for this study

Summary

The aim of the study is to determine the safety of Cilengitide in combination with radiation therapy.

Conditions

  • Diffuse Intrinsic Pontine Glioma

Interventions

DRUG

Cilengitide dose escalation

Cilengitide will be administered intravenously over 60 minutes, twice a week, at a given dose. The Cilengitide dose (mg/m²/infusion)levels are as follows : * 240 * 480 * 720 * 1200 * 1800

DRUG

Cilengitide

Patients will be treated at the recommended dose in order to confirm the recommended cilengitide dose and to carry out the exploratory investigations

RADIATION

Concomitant radiotherapy

1.8 Gy per fraction for a total of 54 Gy over 6 weeks, from monday to friday of the first cycle. The radiation will imperatively begin between 3 and 7hours after the end of Cilengitide infusion.

BIOLOGICAL

Pharmacokinetic

A pharmacokinetic assessment for Cilengitide will be carried for all patients. The pharmacokinetic (PK) samples will be drawn during day 1 and day 2 of the first cycle of treatment.

BIOLOGICAL

Pharmacogenetic

For every patient 1 blood sample will be taken before study treatment. These blood samples can be made at any hour of the day, and does not require to be taken on an empty stomach. DNA will be extracted in the Laboratory of Pharmacology.Constitutional polymorphisms of genes will be measured before the treatment initiation.

BIOLOGICAL

Exploratory investigation

Evaluate the metabolic impact of the treatment with dynamic MRI (diffusion, perfusion, spectro), and with FDG-PETand sestamibi SPECT.

Sponsors & Collaborators

  • Centre Oscar Lambret

    lead OTHER

Principal Investigators

  • Pierre LEBLOND, MD · Centre Oscar Lambret

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-06
Primary Completion
2014-01-31
Completion
2015-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01165333 on ClinicalTrials.gov