Brain oedema due to brain tumour Cancer Malignant neoplasm of the brain
Conditions
Interventions
A single dose of 30 mg Kappaproct® (DIMS0150) given as a rectal enema. The patients are followed for 20 days after treatment.
Sponsors
InDex Pharmaceutials AB (Sweden)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult men and women (greater than 18 year) with malignant brain oedema confirmed by MRI/computed tomography (CT), caused by malignant glioma, menigioma or metastatic disease (histological and/or cytological verified) 2. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance 0 - 3 3. Betapred® (betamethasone) dose 8 mg x 2 for more than 24 hours 4. Clinical need for increase of corticosteroid dosage 5. Possibility to perform repeated MRI examinations
Exclusion criteria
Exclusion criteria: 1. History and precence of a clinical significant cardiovascular, hepatic, haematological, endocrine, neurological and psychiatric disease or immune compromised state as judged by the investigator 2. Chemotherapy that has been administrated within 4 weeks prior to inclusion 3. Positive urine pregnancy test in women at enrolment 4. Intake of drug under investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy assessment: measurement of the volume of the brain oedema with MRI, measured at 10 days after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessed at 10 and 20 days after treatment: 1. Efficacy assessment: Clinical assessment of symptoms of brain edema, dose of steroids, in an explorative manner immune response in blood will be followed. 2. Safety and tolerability after one dose of Kappaproct® treatment In an explorative manner, immune response in blood will be studied. This samples are collected before treatment and at 24 hours and 10 days after treatment. | — |
Countries
Sweden
Outcome results
None listed