Prospective, randomised (using minimisation), double-blind, placebo controlled study to evaluate the safety and efficacy of human normal immunoglobulin as a prophylactic agent against infections in patients with high grade gliomas

• Conditions: Patients with high-grade gliomas (world health organisation [WHO] grade III or IV) in the first relapse after first-line therapy including chemotherapy with or without nitrososurea, with a life expectancy of at least 6 months and undergoing active treatment with chemotherapy

• Registration Number: EUCTR2007-005548-25-DE
• Lead Sponsor: Freistaat Bayern, vertreten durch Klinikum der Universität Regensburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Male and female patients = 18 years old
2.Patients with histologically confirmed high-grade gliomas (WHO Grade III or IV) in the first relapse
3.Patients undergoing first-line therapy containing a nitrosourea or non-nitrosourea based chemotherapy regimen
4.Life expectancy of at least 6 months (defined by the criteria: absence of midline shift and clinical brain pressure signs)
5.Active treatment with chemotherapy
6.Willing and able to give written informed consent
7.Female patients of child-bearing age must take double-barrier precautions to avoid pregnancy. Allowed double barrier methods are: hormonal agents (Pille”) plus condom, or uterine pessar plus condom.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Participation in another clinical trial
2.Did not receive chemotherapy during first-line treatment
3.Severe infection requiring medical treatment at the time of study inclusion
4.IgA below normal
5.Hypersensitivity to the active ingredient or to the excipient of the Kiovig product.
6.Pregnancy
7.Suspected non-adherence to study procedures and follow up

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified