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Clinical study to assess safety and efficacy of rapamycin in paediatric high grade glioma
EU CTIS ID: 2024-515951-39-00
What this study is testing
The primary objective of the study is to determine safety and tolerability of rapamycin in the treatment of high grade glioma in children
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 3 to 18 years, inclusive.
- 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.
- Histological diagnosis of glioma WHO grade III and IV confirmed by reference pathologist.
- Negative result of the pregnancy test performed within 2 weeks prior to the start of the study in patients of reproductive age.
- Written consent to the use of effective contraception in sexually active patients.
You likely can't join if
- Any severe comorbid disease (eg kidney insufficiency, immunological deficiencies, HIV infection).
- Live vaccine intake <6 weeks prior to study inclusion
- Receipt of inactivated vaccine or mRNA vaccine <4 weeks prior to study inclusion.
- Clinically significant cardiovascular condition ( eg arrythmia)
- Previous (< 5 yrs ) diagnosis of malignant neoplasm.
- Active infection requiring systemic treatment.
See the full eligibility criteria
- Age 3 to 18 years, inclusive.
- 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.
- Histological diagnosis of glioma WHO grade III and IV confirmed by reference pathologist.
- Negative result of the pregnancy test performed within 2 weeks prior to the start of the study in patients of reproductive age.
- Written consent to the use of effective contraception in sexually active patients.
- Any severe comorbid disease (eg kidney insufficiency, immunological deficiencies, HIV infection).
- Live vaccine intake <6 weeks prior to study inclusion
- Receipt of inactivated vaccine or mRNA vaccine <4 weeks prior to study inclusion.
- Clinically significant cardiovascular condition ( eg arrythmia)
- Previous (< 5 yrs ) diagnosis of malignant neoplasm.
- Active infection requiring systemic treatment.
- Known allergy to the studied products.
- Concomitant use of CYP3A or PgP inhibitors
- Radiological evidence of active intracranial hemorrhage (excluding receding post biopsy or focal bleeding).
- Major surgery in the past 28 days
- Diagnosis of DIPG
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.