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

September 14, 2011 updated by: University of Zurich

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: 3 years
3 years
PFS, OS translational research
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Silvia Hofer, MD, UniversitaetsSpital Zuerich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 22, 2007

First Submitted That Met QC Criteria

July 11, 2008

First Posted (Estimate)

July 14, 2008

Study Record Updates

Last Update Posted (Estimate)

September 15, 2011

Last Update Submitted That Met QC Criteria

September 14, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEPO906A2401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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