- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00715013
Patupilone (EPO 906) in Patients With Recurrent or Progressive Glioblastoma
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
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Silvia Hofer, MD, Universitaetsspital Zuerich
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Recurrence
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Epothilone B
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.
Clinical Trials on Recurrent Glioblastoma Planned for Reoperation
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); University of California, Los Angeles; Oncoceutics...WithdrawnRecurrent Glioblastoma | Recurrent Gliosarcoma | Recurrent Supratentorial Glioblastoma | Supratentorial GliosarcomaUnited States
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