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ISRCTN
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ISRCTN84460768
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ClinicalTrials.gov identifier
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Public title
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Effect of additional single or repeated dosage of Kappaproct® to corticosteroid treated patients with brain oedema caused by brain tumour
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Scientific title
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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
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Acronym
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Kappaproct® study
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Serial number at source
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InDex-CSBTE-01-09
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Study hypothesis
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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).
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Ethics approval
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Local Ethical Committee in Umeå approved on the 1st April 2009 (ref: 09-054M)
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Study design
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Open one armed non-randomised multicentre trial
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Countries of recruitment
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Sweden
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Disease/condition/study domain
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Brain oedema due to brain tumour
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/11/2009
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Anticipated end date
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31/10/2011
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Total = 30 patients. An evaluation will be done after 10 patients.
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Interventions
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A single dose of 30 mg Kappaproct® (DIMS0150) given as a rectal enema. The patients are followed for 20 days after treatment.
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Primary outcome measure(s)
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Efficacy assessment: measurement of the volume of the brain oedema with MRI, measured at 10 days after treatment.
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Secondary outcome measure(s)
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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.
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Sources of funding
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InDex Pharmaceutials AB (Sweden)
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Trial website
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Publications
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Contact name
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Dr
Thomas
Asklund
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Address
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Department of Oncology
Norrlands University Hospital
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City/town
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Umeå
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Zip/Postcode
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SE-90185
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Country
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Sweden
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Sponsor
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InDex Pharmaceutials AB (Sweden)
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Address
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Scheeles väg 2
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City/town
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Stockholm
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Zip/Postcode
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SE-171 77
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Country
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Sweden
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Email
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svante.rasmuson@indexpharmab.com
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Sponsor website:
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http://www.indexpharmab.com/
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Date applied
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22/10/2009
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Last edited
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02/12/2009
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Date ISRCTN assigned
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02/12/2009
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