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

University of Zurich (UZH)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Recurrent Glioblastoma Planned for Reoperation

Treatments

Drug: Patupilone

Study type

Interventional

Funder types

Other

Identifiers

NCT00715013

CEPO906A2401

Details and patient eligibility

About

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

Full 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.

Enrollment

9 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.