Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication - BIOMEDE

Gustave Roussy0 sites250 target enrollmentStarted: August 2, 2018Last updated: July 20, 2020

Conditions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Active, not recruiting
Sponsor
Enrollment: 250

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional clinical trial of medicinal product

Eligibility Criteria

Sex: All

Inclusion Criteria

•*Diagnosis of DIPG (clinical and radiological, or histological in case the biopsy was performed before study entry)
•*DIPG at diagnosis: no prior chemotherapy for the present cancer; no prior cerebral radiation therapy. NB : Metastatic disease allowed. Patient with metastatic disease are eligible for the study (including the randomised trial if diagnosis of DIPG confirmed). In this situation, radiotherapy will have to start within three weeks after the biopsy while targerted treatment will start at the end of the irradiation.
•*Age > 6 months and < 25 years. For children below the age of 3 years, inclusion in the study and medical decisions should be discussed with the coordinating investigator.
•*Eligible for a biopsy, or biopsy performed for diagnostic purpose and material available for the biomarker assessment
•*Eligible for cerebral radiotherapy
•*Patient covered by an health insurance if national requirement
•*Written informed consent given by patient and/or parents/legal representative for biomarkers assessment and registration in the study.
•*Eligibility criteria for the study (see above)
•*Confirmed histological diagnosis of diffuse intrinsic pontine glioma (grade II, III, IV WHO), confirmed by central pathology review .
•*Life expectancy > 12 weeks after the start of study treatment
•*Karnofsky performance status scale or Lansky Play Scale > 50%.
•*Absolute neutrophil 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 NCI-CTCAE version 4.0 especially cardiovascular, pulmonary or renal disease (, including but not limited to: congenital long QT syndrome, nephrotic syndrome, glomerulopathy, uncontrolled high blood pressure despite adequate treatment, interstitial lung disease, pulmonary arterial hypertension). In case of known or possible cardiac disease, a cardiological advice will be required prior to the inclusion in the randomized trial as a preexisting cardiopathy represents a contra-indication to dasatinib.
•*Effective and appropriate contraception for patients (male and female) of reproductive potential during their entire participation in the study and during 6 months after the end of treatment
•*Negative pregnancy test (serum beta-HCG) evaluated in the last week in females of reproductive potential
•*Written informed consent given by the patient / legal representative for treatment and randomization
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 250
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 5
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•*Massive intratumour bleeding
•*Any other concomitant anti-cancer treatment not foreseen by this protocol
•*Any other cancer during the last 5 years
•*Uncontrolled intercurrent illness or active infection
•*Any other co-morbid condition that in the investigator’s opinion would impair study participation
•*Unable for medical follow-up (geographic, social or mental reasons)
•*Patient not fulfilling one of the previous eligibility criteria.
•*Patient previously treated with irradiation on the brainstem for another neoplasm
•*Patient with congenital galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
•*Patient not covered by a social security agreement accepted in the treating country if national requirement
•*Pregnant or breast feeding women
•*NB: A patient with known hypersensitivity for one the drug or its excipients could still participate to the study and receive one of the other drug(s)

Investigators

Sponsor

Gustave Roussy

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