Multicentric pilot study for the treatment of medulloblastoma in adults - NOA-7

Klinik für Neurologie der Universität Regensburg0 sites33 target enrollmentStarted: August 23, 2012Last updated: August 19, 2024

Conditions

Trial Snapshot

No summary available.

•Age of at least 18 years (see chapter 5)
•Medulloblastoma (+/- post operative residual tumor, M0) respectively medulloblastoma
•(+/- post operative residual tumor, M1-3) (local pathologist, reference histological confirmed immediately after study participation (see chapter 5 and Annex)
•Initial diagnosis of the tumor
•None prior chemotherapy or radiotherapy
•Performance status >= 70%
•Intact blood count (postoperative): leucocytes>= 3000/µl; thrombocytes >= 100000/µl; hemoglobin (Hb) >= 10 g/dl
•Intact liver and kidney function: Creatinine <= 1.5 times of upper limit; Bilirubin <= 1.5 times of upper limit, glutamic pyruvic transaminase (GPT), glutamic oxaloacetic transaminase (GOT), alkaline phosphatase (AP) <= 2.5 times of upper limit
•Clinical and chemically exclusion of HIV or hepatitis C/B infection
•Exclusion psychical, familial, social and geographical factors, which could effect the patient compliance
•Patients, who are in a position to achieve all study requirements
•Patients who are willing to use contraception during treatment. Women of childbearing potential have to be tested negative by a pregnancy test in the baseline examination. Men and women have to practice an effective method of contraception (double barrier) during the study and at least 6 month after discontinuing study medication, this also applies patients with known infertility.
•Written informed consent

•Age < 18 years (see chapter 5)
•Histological not considered medulloblastoma
•Prior treated recurrent tumor by radiotherapy or chemotherapy
•Other tumor diseases (in exception a chirurgical cured carcinoma in situ of cervix and a non-melanocytic skin tumor)
•Allergy or contraindication against one of the substances used in the study
•Participation in other therapy studies
•Severe affecting, life-limiting diseases according to the investigator and also every other medical condition precluding adequate execution of the trial from treating physican’s point of view.
•Women of childbearing potential planning to become pregnant, are pregnant or are breast-feeding, and/or not willing to practice an adequate method of contraception;
•Men not willing to practice an adequate method of contraception

Sponsor

Klinik für Neurologie der Universität Regensburg