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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00715013

Enrollment

Registered

2008-07-14

Start date

2008-07-31

Completion date

2010-12-31

Last updated

2011-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Glioblastoma Planned for Reoperation

Keywords

recurrent Glioblastoma

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.

Interventions

DRUGPatupilone

Patupilone

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Progression free survival	3 years
PFS, OS translational research	3 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026