Condition category
Cancer
Date applied
22/10/2009
Date assigned
02/12/2009
Last edited
02/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Thomas Asklund

ORCID ID

Contact details

Department of Oncology
Norrlands University Hospital
Umeå
SE-90185
Sweden

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 measures

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

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

http://www.indexpharmab.com/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes