DRKS00005584
Completed
Phase 4
Maintenance therapy with Everolimus in patients with tuberous sclerosis successfully treated for subependymal giant cell astrocytoma - EMINENTS (Everolimus MaINtENance Therapy in SEGA)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Q85.1
- Sponsor
- Medical University of Lodz
- Enrollment
- 12
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of Tuberous sclerosis and supependymal giant astrocytoma.
- •At least 12 months everolimus treatment resulting in reduction (more than 30% decrease of tumor volume) or stabilization (less than 20% increase in tumor volume) of SEGA volume.
- •No signs of increased intracranial pressure/no hydrocephalus in MRI
- •Signed informed consent to the trial.
Exclusion Criteria
- •No diagnosis of TSC
- •Age \> 20 years
- •Progression (more than 20% increase of tumor volume) of SEGA volume during everolimus treatment in standard dose.
- •Signs of increased intracranial pressure/hydrocephalus in MRI during everolimus treatment in standard dose.
- •No signed informed consent to the trial.
Outcomes
Primary Outcomes
Not specified
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