Patupilone (EPO 906) in Patients With Recurrent or Progressive Glioblastoma

Prior to and after re-operation patients with recurrent glioblastoma receive the investigational drug Patupilone, a tubulin-inhibitor.

The purpose of the trial is to prolong PFS in this patient population. Patupilone is already used in clinical trials of other tumor entities such as ovarian cancer, breast and lung cancer. Side effects are expected to be manageable.

Inclusion criteria

• Recurrent glioblastoma at least 2 cm in diameter after standard treatment (Surgery, Radiotherapy and Chemotherapy), which has to be completed at least three weeks earlier.
• > 18 years of age, KPS 70-100%
• No liver disease, no malignancies (except curative treated skin tumors, DCIS of the breast and curative treated cervix carcinoma)
• Lc > 3000 und Tc > 100 000, Hb> 9, Bilirubin </= 1.5mg/dl, AST/ALT less than 2.5 x upper limit, creatinine </= 132umol/l
• No pregnancy or breast feeding
• Written Informed Consent prior to study entry
• No reasons for incompliance
• Reoperation planned

Exclusion criteria

• KPS < 70%
• Radiotherapy- or Chemotherapy within 6 weeks
• Enzyme inducing medication or St John's wort
• Other study medication within 28 days
• Other malignancies
• Intolerance of Patupilone
• Prior Patupilone
• Neuropathy > Grad 1
• Other life threatening illnesses
• Acute or chronic liver diseases
• HIV Infection
• Known non-compliance in medication intake,inability to give informed consent
• Cardiac problems (NYHA III oder IV) with uncontrolled insufficiency or angina pectoris
• Active or uncontrolled infection
• Pregnancy or breast feeding
• Hematologic Growth Factors (without Erythropoetin) colostomy
• Patients with uncontrolled diarrhea in the last 7 days prior to study entry.