Q85.1 D33.0
Conditions
Interventions
Group 1: Intervention study: TSC patient with SEGA after standard 12 months of everolimus (Votubia, Novartis, Germany) treatment with reduction (more than 30% decrease of tumor volume) or stabilizati
Sponsors
Medical University of Lodz
Eligibility
Sex/Gender
All
Age
0 Months to 20 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with stable or acceptable increase of SEGA volume, defined as no changes in the total volume of all target SEGA or increase less than 50% relative to baseline and no greater than volume before start of everolimus treatment, no new lesions of 1 cm or greater in diameter, and new or worsening hydrocephalus. Magnetic resonance evaluation will be performed at the study entery and after 3, 6, 12, 18, 24 months of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression of subependymal giant cel astrocytoma. Number, type and severity of complications of everolimus treatment in reduced dose. Clinical evaluation of the progression and presence of the treatment-related side effects will be performed during monthly follow-u visits. | — |
Countries
Poland
Contacts
Public ContactJoanna Trelinska
Medical University of Lodz
Outcome results
None listed