Maintenance therapy with Everolimus in patients with tuberous sclerosis successfully treated for subependymal giant cell astrocytoma

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00005584
• Date of registration: 03/03/2015
• Prospective Registration: No
• Primary sponsor: Medical University of Lodz
• Public title: Maintenance therapy with Everolimus in patients with tuberous sclerosis successfully treated for subependymal giant cell astrocytoma
• Scientific title: Maintenance therapy with Everolimus in patients with tuberous sclerosis successfully treated for subependymal giant cell astrocytoma - EMINENTS (Everolimus MaINtENance Therapy in SEGA)
• Date of first enrolment: 18/12/2013
• Target sample size: 15
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00005584
• Study type: interventional
• Study design: Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: treatment
• Phase: 4

Countries of recruitment

Poland

Contacts

• Name: Joanna Trelinska
• Affiliation: Medical University of Lodz

• Name: Joanna Trelinska
• Affiliation: Medical University of Lodz, Departmentof Peidatrics, Oncology, Hematology and Diabetology

Key inclusion & exclusion 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.


Age minimum: 0 Months
Age maximum: 20 Years
Gender: All

Health Condition(s) or Problem(s) studied

Tuberous sclerosis

D33.0

Q85.1
D33.0

Brain, supratentorial

Q85.1

Intervention(s)

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 stabilization (less than 20% increase in tumor volume) of SEGA volume. The everolimus dose will be reduced to three times a week (Monday, Wednesday, Friday) with the same daily dose (reduction of week dose from 17.5mg-87.5mg to 7.5mg-37.5mg respectively to patients individual initial dose).

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

2015-000941-22

U1111-1152-1134

Source(s) of Monetary Support

Medical University of Lodz

Ethics review

Status: Approved
Approval date: 17/12/2013
Contact:

Bioethics Committee of the Medical University of Lodz

4842 272 52 05

Results

• URL: http://drks.de/search/en/trial/DRKS00005584#studyResults