Status:
COMPLETED
Cilengitide in Combination With Irradiation in Children With Diffuse Intrinsic Pontine Glioma
Lead Sponsor:
Centre Oscar Lambret
Conditions:
Diffuse Intrinsic Pontine Glioma
Eligibility:
All Genders
6-21 years
Phase:
PHASE1
Brief Summary
The aim of the study is to determine the safety of Cilengitide in combination with radiation therapy.
Detailed Description
The prognosis of children and young adults with a malignant glioma in the brain stem or a recurrent malignant glioma (in whatever site) is very poor. Over the last few decades, many therapeutic trials...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01165333
Start Date
August 1 2010
End Date
March 1 2015
Last Update
February 17 2016
Active Locations (9)
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1
Hôpital des Enfants, Groupe Hospitalier
Bordeaux, France, 33076
2
Centre Oscar Lambret
Lille, France, 59020
3
Centre Léon Bérard
Lyon, France, 69373
4
CHU, Hôpital d'Enfants de la Timone
Marseille, France, 13385