Multicentric pilot study for the treatment of medulloblastoma in adults
- Conditions
- C71.6Cerebellum
- Registration Number
- DRKS00002072
- Lead Sponsor
- Klinik für Neurologie der Universität Regensburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 33
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compatibility, number of discontinuation due to toxicity
- Secondary Outcome Measures
Name Time Method 3 and 5 year progression-free survival (PFS)