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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Oscar Lambret

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)