Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT01165333
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
21 Years
Study:
NCT01165333
Study Brief:
Protocol Section:
NCT01165333