EUCTR2005-003101-85-DEActive, not recruitingNot Applicable
Phase-III study of standard radiotherapy plus concomitant and adjuvant OSAG 101 (Theraloc®) plus Temozolomide vs. standard radiotherapy plus concomitant and adjuvant Temozolomide in patient with newly diagnosed, histologically confirmed glioblastoma multiforme grade IV
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Oncoscience AG
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Each study patient must meet all of the following conditions:
- •Investigator verifies patient's mental capacity to consent.
- •Patient signed informed consent
- •Histologically verified diagnosis of glioblastoma multiforme grade IV
- •Age 18-70
- •Karnofsky-Index >70
- •Female patients with a childbearing potential must have a negative pregnancy test within one week before inclusion in the trial. Those female and male patients admitted in the study must use a reliable method of contraception (e.g. birth-control-pill, condom).
- •Treatment in a study center
- •Adequate haematological, renal and hepatic function according to the following definitions:
- •Leucocytes >2.0x10 9/l
- •Platelets = 50 x 10 9/l
- •Hb > 10g/dl
- •Billirubin total < 2.5x upper limit of normal (ULN)
- •Creatinin i.S. < 1.5x ULN
- •AST (GOT)/ALT (GPT) < 5x ULN
- •Patients must be available during the treatment period and be able to comply with the study plan.
- •MRI compatibility
- •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) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •None of the following conditions are permitted for a study patient:
- •If investigator has any concerns regarding patient's mental condition or if patient is under disability, patient must not be randomized
- •Previous participation in this study
- •Prior chemotherapy or X-ray therapy or other experimental treatments during this study
- •Participation in another therapeutic study involving the basic condition
- •Females of childbearing age with insufficient or inadequately assured contraception
- •Pregnancy or lactation
- •Other existing serious conditions that could adversely affect the patient's therapy in accordance with the protocol
- •Any other condition or therapy which in the opinion of the attending physician could represent a risk for the patient or interfere with study objectives
- •Known contraindications against antibodies (e.g., prior treatment with recombinant/monoclonal antibodies)
- •Missing or incomplete statement of consent
- •Patients with evidence of second malignancy
- •MRI not feasible
Investigators
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