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

Sponsor
University of Zurich (Other)
Overall Status
Completed
CT.gov ID
NCT00715013
Collaborator
(none)
9
Enrollment
29
Duration (Months)

Study Details

Study Description

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
Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Outcome Measures

Primary Outcome Measures

  1. Progression free survival [3 years]

  2. PFS, OS translational research [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Zurich

Investigators

  • Principal Investigator: Silvia Hofer, MD, UniversitaetsSpital Zuerich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00715013
Other Study ID Numbers:
  • CEPO906A2401
First Posted:
Jul 14, 2008
Last Update Posted:
Sep 15, 2011
Last Verified:
Aug 1, 2011
Keywords provided by University of Zurich
recurrent Glioblastoma
Additional relevant MeSH terms:
Glioblastoma
Recurrence
Epothilone B

Study Results

No Results Posted as of Sep 15, 2011