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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Patupilone trial for patients with recurrent glioblastoma, which are planned for re-operation. Objectives: prolongation of PFS compared to patients with re-operation only, Patupilone tumor concentrations, pharmacokinetic, Perfusion in MRI pre - and post Patupilone. Translational research of tumor tissue exposed to patupilone.

• Trial with medicinal product

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Treatments: Epothilone B; Epothilones

Criteria

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, Bilirubinupper limit, creatinine
• 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.