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

Study Overview
=================
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 concentrations, pharmacokinetic, Perfusion in MRI pre - and post Patupilone. Translational research of tumor tissue exposed to patupilone. Trial with medicinal product

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 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.

Official Title
-----------------
Patupilone (EPO 906) in Patients With Recurrent or Progressive Glioblastoma Multiforme Prior to and After Secondary Resection: an Open-label Phase I/II Trial.

Conditions
-----------------
Recurrent Glioblastoma Planned for Reoperation

Intervention / Treatment
-----------------
* Drug: Patupilone


Participation Criteria
=================
Eligibility 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, 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Patupilone|Patupilone|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 3 years | 
| PFS, OS translational research |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent Glioblastoma