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

Recurrent Glioblastoma Planned for Reoperation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715013
• Other study ID #: CEPO906A2401
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 22, 2007
• Last updated: September 14, 2011
• Start date: July 2008
• Est. completion date: December 2010

Study information

• Verified date: August 2011
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma
• Recurrent Glioblastoma Planned for Reoperation

Intervention

Drug:
• Patupilone
Patupilone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		3 years
Primary	PFS, OS translational research		3 years