Effect of additional single or repeated dosage of Kappaproct® to corticosteroid treated patients with brain oedema caused by brain tumour
- Conditions
- Brain oedema due to brain tumourCancerMalignant neoplasm of the brain
- Registration Number
- ISRCTN84460768
- Lead Sponsor
- InDex Pharmaceutials AB (Sweden)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy assessment: measurement of the volume of the brain oedema with MRI, measured at 10 days after treatment.
- Secondary Outcome Measures
Name Time Method Assessed at 10 and 20 days after treatment:<br>1. Efficacy assessment: Clinical assessment of symptoms of brain edema, dose of steroids, in an explorative manner immune response in blood will be followed.<br>2. Safety and tolerability after one dose of Kappaproct® treatment<br><br>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.