Patients with increasing clinical symptoms of brain edema caused by brain tumor or brain metatstasis, on maximum dose of corticosteroids will be asked to participate in the study. The brain edema must be confirmed by MRI MedDRA version: 9.1 Level: LLT Classification code 10006121 Term: Brain edema
Conditions
Interventions
Product Name: Kappaproct
Product Code: DIMS0150
Pharmaceutical Form: Enema*
Current Sponsor code: DIMS0150
Other descriptive name: AEL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration t
Sponsors
InDex Pharmaceuticals AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults (>18 year) with malignant brain edema confirmed by MRI, caused by malignant glioma; menigioma or metastatic disease, - WHO/ECOG performance 0- 3 - Betapred (betamethasone) dose 8 mg x 2 for more than 24 hours - Clinical need for increase of corticosteroid dosage - Written informed consent obtained Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •History and precence of a clinical significant cardiovascular, hepatic, heamatological, endocrine, neurological and psychiatric disease or immune compromised state as judged by the investigator •Chemotherapy that has been administrated within 4 weeks prior to inclusion. •Positive urine pregnancy test in women at enrolment On treatment with other investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the effect of an additional single dose of Kappaproct to corticosteroid treated patients with brain edema caused by brain tumor, measured as reduction of the volume of the edema by MRI;Secondary Objective: -Safety and tolerability after one dose of Kappaproct -Pharmacodynamic analyses - In an explorative manner study the immune response in blood from patients before and after the treatment with Kappaproct including cytokine profiles and other factors believed to indicate status of steroid resistance, steroid re-sensitization and effects on the immune system. Examples of factors that will be analyzed are IL-10, IP-10, interferons and specific biomarkers for steroid response and immune system biomarkers such as CD20. -Possible reduction of steroids -Reduction of clinical symptoms of brain edema, judged by the investigator ;Primary end point(s): Volume of brain edema measured by MRI compared to baseline Record of change in steroid doses (daily changes) Assessment of clinical symptoms (assessed by the investigator) | — |
Countries
Sweden
Outcome results
None listed