high grade glioma
Conditions
Sponsors
The Children's Memorial Health Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 3 to 18 years, inclusive. 2. Informed consent signed by parents or legal guardian of minor and by patient over 13 years of age) for the study diagnostic and therapeutic procedures, including molecular -based diagnostic and prognostic tests using NGS method. 3. Histological diagnosis of glioma WHO grade III and IV confirmed by reference pathologist. 4. Negative result of the pregnancy test performed within 2 weeks prior to the start of the study in patients of reproductive age. 5. Written consent to the use of effective contraception in sexually active patients. Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any severe comorbid disease (eg kidney insufficiency, immunological deficiencies, HIV infection). 2. Clinically significant cardiovascular condition ( eg arrythmia) 3. Previous (< 5 yrs ) diagnosis of malignant neoplasm. 4. Active infection requiring systemic treatment. 5. Known allergy to the studied products. 6. Concomitant use of CYP3A or PgP inhibitors. 7. Radiological evidence of active intracranial hemorrhage (excluding receding post biopsy or focal bleeding). 8. Major surgery in the past 28 days 9. Diagnosis of DIPG 16. Live vaccine intake <6 weeks prior to study inclusion, 17. Receipt of inactivated vaccine or mRNA vaccine <4 weeks prior to study inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to determine safety and tolerability of rapamycin in the treatment of high grade glioma in children;Secondary Objective: -The secondary aim of the study is to asses safety and efficacy of rapamycin in a treatment of high grade glioma in children. -The ecsplorative aim of the study is to collate genetic and epigenetic markers with the rapamycine efficacy and safety in pediatric high grade glioma patients. ;Primary end point(s): The primary safety endpoint of rapamycin will be the assessment of the incidence of 3 and 4 grade adverse reactions (according to the CTCAE classification) during the treatment phase and follow-up.;Timepoint(s) of evaluation of this end point: - interim analysis -final analyses after the formal final database lock, planned within one month after the last patient last visit in the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • OS (overall survival) after 15 months, 24 months, 3 years, 5 years, • EFS (event free survival) after 15 months, 24 months, 3 years, 5 years, • PFS (progression free survival) after 15 months, 24 months, 3 years, 5 years, • ORR ( overall response rate) according RAPNO (CR, PR, SD, PD) criteria, • Evaluation of adverse event seriousness according CTCAE, • Evaluation of the number of patients who experience adverse events that effects with premature termination of tratment during the therapeutic dose period. OS, EFS and PFS will be counted from the start of cancer treatment (the day of surgery). ;Timepoint(s) of evaluation of this end point: After 15 months, 24 months, 3 years and 5 years from the start of cancer treatment (the day of surgery) | — |
Countries
Poland
Contacts
Public ContactMarta Perek-Polnik
The Children's Memorial Health Institute
Outcome results
None listed