Temozolomide and pegylated (PEG)-liposomal Doxorubicin in first line treatment of patients with Glioblastoma WHO Grad IV

• Conditions: newly diagnosed Glioblastoma multiforme WHO Grade IV

• Registration Number: EUCTR2006-001375-38-AT
• Lead Sponsor: Klinik und Poliklinik für Neurologie der Universität Regensburg am Bezirksklinikum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Histopathologically confirmed glioblastoma multiforme (GBM, WHO grade IV)
• Age: >= 18 and <= 70 years.
• Karnofsky performance status >= 70%
• Stable, non-increasing dose of corticosteroids 2 weeks before randomization
• Adequate hematological, renal and hepatic function according to all of the following laboratory values (to be performed within 14 days, inclusive, prior to randomization):
• WBC >= 3000/microliter, Hb >= 10 g/dl
• Platelets >= 100000/microliter;
• Serum creatinine < 1.5 times upper limit of laboratory normal;
• Total serum bilirubin < 1.5 times upper limit of laboratory normal;
• ASAT and ALAT < 2,5 times upper limit of laboratory normal;
• Alkaline phosphatase of < 2,5 times upper limit of laboratory normal.
• Absence of known HIV infection, chronic hepatitis B or hepatitis C infection;
• Absence of any other serious medical condition according to the medical judgement of the physician prior to randomization.
• Absence of previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and non-melanoma skin cancer.
• Presence of medically approved contraception in any fertile (M/F) patient.

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

Exclusion Criteria

• prior chemotherapy
• prior radiotherapy to the brain
• Karnofsky performance index < 70%

Study & Design

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