Status:
COMPLETED
Patupilone (EPO 906) in Patients With Recurrent or Progressive Glioblastoma
Lead Sponsor:
University of Zurich
Conditions:
Recurrent Glioblastoma Planned for Reoperation
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief 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 concentrati...
Detailed Description
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 popul...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00715013
Start Date
July 1 2008
End Date
December 1 2010
Last Update
September 15 2011
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