New combo therapy tested for deadly childhood brain cancer
NCT ID NCT01165333
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested whether adding the drug cilengitide to standard radiation is safe for children and young adults with a rare, aggressive brain tumor called DIPG. The main goal was to find the highest safe dose. 32 participants were enrolled. The study did not aim to cure the disease, but to gather safety information for future trials.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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32 people
The number who actually took part.
- Started
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Sep 2010
- Finished
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Mar 2015
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 months to 21 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed diffuse intrinsic pontine glioma * Metastatic disease allowed * MRI measurable disease according to the WHO criteria and for extension cohort * Patient is able to undergo functional MRI (diffusion, perfusion, spectro) * Patient is able to undergo FDG-PET and sestamibi SPECT * Life expectancy \> 8 weeks after the start of study treatment. * No prior chemotherapy for the present cancer; no treatment for any other cancer during the last 5 years. * No prior cerebral radiation therapy * Age \> 6 months and \< 21 years * Lansky Play Scale \> 50 or ECOG Performance Status \< 2; NB: Children and young adults with a worse performance status due to glioma-related motor paresis can be included. * Absolute neutrophils count \> 1.5 x 109/l, Platelets \> 100 x 109/l * Total bilirubin \< 1,5 x ULN, AST and ALT\< 2,5 x ULN * Serum creatinine ≤ 1,5 X ULN for age. If serum creatinine \> 1,5 ULN, creatinine clearance must be \> 70 ml/min/1.73 m² (EDTA radioisotope GFR or 24 hours urines collection) * Normal coagulation tests : prothrombin rate (prothrombin time = PT), TCA (PTT), fibrinogen * No current organ toxicity \> grade 2 according to the NCICTCAE version 4.0, especially cardiovascular or renal disease (nephrotic syndrome, glomerulopathy, uncontrolled high blood pressure despite adequate treatment). In case of known or possible cardiac disease, a cardiological advice will be required prior to the inclusion in the study * If anticonvulsants are currently administered, the dosing regimen must be stable within 1 week prior to the first dose of Cilengitide * If corticosteroids are administered, the dosing regimen must be stable ≥ 5 days prior to the first dose of Cilengitide. * Effective contraception for patients (male and female) of reproductive potential during their entire participation in the study and during 6 months after the last administration of Cilengitide. * Negative pregnancy test (serum beta-HCG) within 1 week prior to start of study treatment in females of reproductive potential * Patient covered by government health insurance * Written informed consent given by patient and/or parents/ guardians prior to the study participation Exclusion Criteria: * Inclusion criteria failure * History of coagulation disorder associated with bleeding or recurrent thrombotic events. * Prior anti-angiogenic therapy * Any other concomitant anti-cancer treatment not foreseen by this protocol. * Concomitant inclusion in another therapeutic clinical trial; participation in another therapeutic clinical trial during the last 30 days. * Pregnancy or breast feeding woman * Uncontrolled intercurrent illness or active infection * Unable for medical follow-up (geographic, social or mental reasons)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU
Toulouse, 33059, France
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CHU, Hôpital d'Enfants de la Timone
Marseille, 13385, France
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Centre Hospitalier Universitaire de Nantes
Nantes, 44093, France
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Centre Léon Bérard
Lyon, 69373, France
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Centre Oscar Lambret
Lille, 59020, France
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Hôpital des Enfants, Groupe Hospitalier
Bordeaux, 33076, France
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Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
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Institut Curie
Paris, 75231, France
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Institut Gustave-Roussy
Villejuif, 94805, France
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Other studies related to the condition(s) this trial covers.
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