NCT00715013

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2008

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2007

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 15, 2011

Status Verified

August 1, 2011

Enrollment Period

2.4 years

First QC Date

November 22, 2007

Last Update Submit

September 14, 2011

Conditions

Recurrent Glioblastoma Planned for Reoperation

Keywords

recurrent Glioblastoma

Outcome Measures

Primary Outcomes (2)

  • Progression free survival

    3 years

  • PFS, OS translational research

    3 years

Interventions

PatupiloneDRUG

Patupilone

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glioblastoma

Interventions

epothilone B

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Silvia Hofer, MD

    UniversitaetsSpital Zuerich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2007

First Posted

July 14, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

September 15, 2011

Record last verified: 2011-08