Status:
TERMINATED
AsiDNA Children, Adolescents and Young Adults
Lead Sponsor:
Institut Curie
Conditions:
Recurrent High-grade Glioma
Eligibility:
All Genders
12-24 years
Phase:
PHASE1
PHASE2
Brief Summary
HGG comprises diffuse midline gliomas (DMG), including diffuse infiltrating brainstem glioma (DIPG), characterised by histone gene mutations, as well as non-DM HGGs mainly in non-midline supratentoria...
Eligibility Criteria
Inclusion
- Written informed consent from patient (depending on age) and/or parents or legal guardian;
- Patient must be ≥ 12 months and \< 25 years of age at the time of enrolment on the study;
- Recurrent high-grade glioma (HGG), including diffuse midline glioma (DMG) and non-DMG, based on RAPNO criteria confirmed by central radiological review, with or without histology if biopsy performed prior to inclusion;
- Available tumour material, at least paraffin embedded and/or also frozen material;
- For DMG and non-DMG HGG, prior radiation dose prescribed ≤ 60 Gy, completed at least 6 months prior to inclusion, with stable disease;
- Maximum cumulative radiation dose to optic chiasm and optic nerve \< 56 Gy and \< 54 Gy to upper cervical spine (at level C1);
- Life expectancy \> 2 months at Screening;
- Patient must have a Lansky (≤ 16 years) or Karnofsky (\> 16 years) score of ≥ 50 % , not taking into account neurological deficit;
- No significant abnormality on laboratory tests at Screening, including:
- Haemoglobin \> 9 g/dL;
- Neutrophils \> 1.0 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;
- Normal coagulation tests.
- No organ toxicity \> grade 2 according to NCI CTCAE version 5.0 classification, notably cardiovascular, pulmonary or renal diseases, including congenital QT prolongation syndrome, nephrotic syndrome, glomerulopathy, uncontrolled high blood pressure despite appropriate treatment, interstitial pulmonary disease, pulmonary hypertension;
- Negative serum pregnancy test for women of child-bearing potential, and highly effective birth control method for male and female patients of reproductive potential;
- Patients covered by social security or health insurance in compliance with the national legislation relating to biomedical research.
Exclusion
- 5\. Prior radiation dose prescribed \> 60 Gy; 6. Massive intra-tumour haemorrhage; 7. Pseudoprogression (including after central review); 8. Metastatic relapse; 9. Other anticancer treatment, on-going or within less than 4 weeks prior to inclusion; 10. Prior or concurrent malignant disease, other than HGG, diagnosed or treated within 5 years prior to inclusion; patients with CMMRD are eligible; 11. Uncontrolled intercurrent disease or active infection; 12. Concomitant disease or other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study; 13. Patients unable to comply with the protocol for any reason; 14. Organ toxicity \> grade 2 according to NCI CTCAE version 5.0 classification, notably cardiovascular, pulmonary or renal diseases, including congenital QT prolongation syndrome, nephrotic syndrome, glomerulopathy, uncontrolled high blood pressure despite appropriate treatment, interstitial pulmonary disease, pulmonary hypertension 15. Breastfeeding or pregnancy
Key Trial Info
Start Date :
May 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05394558
Start Date
May 27 2022
End Date
September 20 2023
Last Update
December 26 2023
Active Locations (10)
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1
Chu Angers
Angers, France, 49033
2
Chru Bordeaux
Bordeaux, France, 33076
3
Centre Oscar Lambret
Lille, France, 59020
4
Centre Leon Berard
Lyon, France, 69373