Cilengitide in Combination With Irradiation in Children With Diffuse Intrinsic Pontine Glioma (NCT01165333) | Clinical Trial Compass
CompletedPhase 1
Cilengitide in Combination With Irradiation in Children With Diffuse Intrinsic Pontine Glioma
France32 participantsStarted 2010-09-06
Plain-language summary
The aim of the study is to determine the safety of Cilengitide in combination with radiation therapy.
Who can participate
Age range6 Months – 21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 anticonvulsa…
What they're measuring
1
Determination of the Maximal Tolerated Dose of Cilengitide