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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00715013
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : September 15, 2011
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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
Recurrent Glioblastoma Planned for Reoperation Drug: Patupilone 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.

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Study Type : Interventional  (Clinical Trial)
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 : July 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Patupilone
    Patupilone


Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 3 years ]
  2. PFS, OS translational research [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715013


Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Silvia Hofer, MD UniversitaetsSpital Zuerich

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00715013    
Other Study ID Numbers: CEPO906A2401
First Posted: July 14, 2008    Key Record Dates
Last Update Posted: September 15, 2011
Last Verified: August 2011
Keywords provided by University of Zurich:
recurrent Glioblastoma
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Epothilone B
Epothilones
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action