Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
InDex-CSBTE-01-09
Study information
Scientific title
Effect of additional single or repeated dosage of Kappaproct® to corticosteroid treated patients with brain oedema caused by brain tumour: a multicentre open one-arm non-randomised trial
Acronym
Kappaproct® study
Study hypothesis
To evaluate the effect of an additional single dose of Kappaproct® to corticosteroid treated patients with brain oedema caused by brain tumour, measured as reduction of the volume of the oedema by magnetic resonance imaging (MRI).
Ethics approval
Local Ethical Committee in Umeå approved on the 1st April 2009 (ref: 09-054M)
Study design
Open one armed non-randomised multicentre trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Brain oedema due to brain tumour
Intervention
A single dose of 30 mg Kappaproct® (DIMS0150) given as a rectal enema. The patients are followed for 20 days after treatment.
Intervention type
Drug
Phase
Phase I/II
Drug names
Kappaproct®
Primary outcome measure
Efficacy assessment: measurement of the volume of the brain oedema with MRI, measured at 10 days after treatment.
Secondary outcome measures
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.
Overall trial start date
01/11/2009
Overall trial end date
31/10/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Total = 30 patients. An evaluation will be done after 10 patients.
Participant 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
Recruitment start date
01/11/2009
Recruitment end date
31/10/2011
Locations
Countries of recruitment
Sweden
Trial participating centre
Department of Oncology
Umeå
SE-90185
Sweden
Sponsor information
Organisation
InDex Pharmaceutials AB (Sweden)
Sponsor details
Scheeles väg 2
Stockholm
SE-171 77
Sweden
svante.rasmuson@indexpharmab.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
InDex Pharmaceutials AB (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list