Effect of additional single or repeated dosage of Kappaproct® to corticosteroid treated patients with brain oedema caused by brain tumour

ISRCTN	ISRCTN84460768
DOI	https://doi.org/10.1186/ISRCTN84460768
Secondary identifying numbers	InDex-CSBTE-01-09

Submission date: 22/10/2009
Registration date: 02/12/2009
Last edited: 02/12/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Thomas Asklund
Scientific

Department of Oncology
Norrlands University Hospital
Umeå
SE-90185
Sweden

Study information

Study design	Open one armed non-randomised multicentre trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	Kappaproct® study
Study objectives	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(s)	Local Ethical Committee in Umeå approved on the 1st April 2009 (ref: 09-054M)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase I/II
Drug / device / biological / vaccine name(s)	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 study start date	01/11/2009
Completion date	31/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Total = 30 patients. An evaluation will be done after 10 patients.
Key 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
Key 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
Date of first enrolment	01/11/2009
Date of final enrolment	31/10/2011

Locations

Countries of recruitment

Sweden

Study participating centre

Department of Oncology

Umeå
SE-90185
Sweden

Sponsor information

InDex Pharmaceutials AB (Sweden)
Industry

Scheeles väg 2
Stockholm
SE-171 77
Sweden

Email	svante.rasmuson@indexpharmab.com
Website	http://www.indexpharmab.com/
"ROR"	https://ror.org/05225cn18

Funders

Funder type

Industry

InDex Pharmaceutials AB (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan