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

Primary Purpose

Recurrent Glioblastoma Planned for Reoperation

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Patupilone

About this trial

This is an interventional treatment trial for Recurrent Glioblastoma Planned for Reoperation focused on measuring recurrent Glioblastoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Progression free survival

PFS, OS translational research

Secondary Outcome Measures

Full Information

NCT ID

NCT00715013

First Posted

November 22, 2007

Last Updated

September 14, 2011

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT00715013

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

4. Oversight

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Glioblastoma Planned for Reoperation

Keywords

recurrent Glioblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Patupilone

Intervention Description

Patupilone

Primary Outcome Measure Information:

Title

Progression free survival

Time Frame

3 years

Title

PFS, OS translational research

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Silvia Hofer, MD

Organizational Affiliation

UniversitaetsSpital Zuerich

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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