Epothilone in Recurrent Glioblastoma Patients

Inclusion Criteria:

* Age between 18 and 70 years
* KPS ≥ 70
* Life expectancy of at least 3 months
* Presence of at least one bi-dimensionally measurable lesion on gadolinium (Gd)-enhanced MRI, indicating progressive or recurrent disease at least 8 weeks after standard external-beam radiotherapy
* Recurrence or progression after treatment with radiotherapy and temozolomide. Also patients with residual disease after surgery for recurrent GBM will be included
* Adequate bone marrow reserve (leukocytes ≥ 3,500/ml, ANC ≥ 1,500/ml, platelets ≥100,000/ ml); normal baseline liver (serum bilirubin ≤ 20 /mol/ L), renal (serum creatinine \<150 /mol/L) and cardiac function
* Absence of infectious disease, debilitating chronic diseases, and known psychiatric disorders
* Corticosteroid dose stable for at least 1 week
* Adequate recovery from previous surgery, radiation and chemotherapy
* Negative pregnancy test at enrolment in females of child-bearing potential
* Agreement to use highly effective contraception methods in adults of reproductive potential
* Fully informed written consent

Exclusion Criteria:

* Pregnant women
* Patients who have had chemotherapy or radiotherapy within 4 weeks
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZK219477
* Uncontrolled inter current illness including, but not limited, to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* HIV-infection
* Any prior treatment with epothilones, other tubulin-targetting as taxanes (e.g. paclitaxel, docetaxel) and vinca alkaloids (e.g. vincristine, vinblastine, vinorelbine)
* Peripheral neuropathy
* Any concurrent malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix
* Active infection
* Breast-feeding
* Subjects who have received an experimental drug or have participated in a clinical trial within 3 months prior to screening
* Employees of the investigator or study centre with direct involvement in the proposed study or other studies under the direction of that investigator or study centre