Adults With Glioblastoma Multiforma Clinical Trial
Official title:
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
| Verified date | November 2012 |
| Source | Oncoscience AG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Paul-Ehrlich-Institut |
| Study type | Interventional |
Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | January 2012 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Patient signed informed consent - Newly diagnosed, histologically confirmed glioblastoma multiforme grade IV - Condition is measurable by MRI in at least one dimension - Age 18-70 - Karnofsky-Index > 40 - Treatment in a study center - 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. - Adequate haematological, renal and hepatic function: - Leucocytes >2.0x10^9/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 Exclusion Criteria: - Patients with history of anaphylactic reaction to murine or humanized antibody - Patients with evidence second malignancy - Patients who are pregnant or patients who refused adequate contraceptive precaution (female and male) during the trial - Pregnancy and lactation - Other conditions considered by investigators as sound reasons for disqualification from enrolment into the study such as: potential non compliance with protocol requirement - No MRI for tumour evaluation |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Dep. Neurosurgery, Univ. Hamburg | Hamburg |
| Lead Sponsor | Collaborator |
|---|---|
| Oncoscience AG | Dep. of Neurosurgery and Policlinic, University Hospital, Dresden, Germany, Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany, Heinrich-Heine University, Duesseldorf, Johann Wolfgang Goethe University Hospitals, Neurological Clinic of the University of Tübingen, Tübingen, Germany, Neurological Clinic, Knappschaftskrankenhaus Bochum-Langendreer, Bochum, Germany, Universitätsklinikum Hamburg-Eppendorf, University of Bonn, University of Giessen, University of Kiel |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free interval determined by MRI | week 12, 24, 36, 52 | ||
| Secondary | Overall survival Time to reintervention Response rate according to RECIST criteria Toxicity according to CTC criteria Symptom control Quality of life | week 12, 24, 36, 52 |