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Phase 1/Phase 2
18 Years
65 Years
Open (Enrolling)

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Trial Information

Inclusion Criteria:

- age > 18 years

- medulloblastoma (+/- postoperative residual tumor, M0) or medulloblastoma (+/-
postoperative residual tumor, M1-M3) respectively

- primary diagnosis of the tumor

- no previous chemo- or radiation therapy

- Karnofsky-Index ≥ 70%

- WBC ≥ 3000/μl; thrombocytes ≥ 100 000/μl; Hb ≥ 10 g/dl

- creatinine =< 1,5 ULN; Bilirubin =< 1,5 ULN; GPT, GOT, AP =< 2,5 ULN

- HIV and hepatitis B/C negative

- no factors / any medical condition affecting patient's compliance

- patient needs to fulfil protocol's requirements

- patient is willing to use highly effective methods of contraception during dosing and
for 6 months after the last dose; women of child-bearing potential must have a
negative hCG laboratory test at baseline; pregnancy tests must be repeated every 4

- patient's written consent

Exclusion Criteria:

- age < 18 years

- histologically not confirmed Medulloblastoma

- by chemo- or radiotherapy treated recidive tumor

- other cancer (with exception of surgically cured carcinoma in situ of the cervix and
non-melanocytic skin tumors)

- hypersensitivity or contraindication against one of the used drugs

- current or planned participation to another clinical trial during this study Any
other condition which, in the opinion of the Investigator, would make the patient
unsuitable for enrolment or could interfere with the patient participating in and
completing the study

- Any medical condition associated with high medical risk or contraindicated to use
chemotherapeutic agents as indicated in current product package insert

- Pregnant or nursing (lactating) women; women or men not willing to use a highly
effective methods of contraception

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

feasibility of the adjuvant chemotherapy

Outcome Description:

The main objective is the feasibility of the adjuvant chemotherapy which has gained the best results when combined with radiotherapy so far. The present protocol is primarily to determine the number of interruptions of the maintenance chemotherapy due to toxicity and the kind of toxicity .

Outcome Time Frame:

participants will be followed for the duration of chemo therapy, an expected average of 1 year

Safety Issue:


Principal Investigator

Ulrich Bogdahn, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Neurology, University of Regensburg


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

January 2009

Completion Date:

July 2014

Related Keywords:

  • Medulloblastoma
  • medulloblastoma
  • CNS
  • malignant neoplasm
  • NOA
  • neuroectodermal tumor
  • Vincristin
  • CCNU
  • Cisplatin
  • Medulloblastoma