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

NCT ID: NCT00715013

Last Updated: 2011-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-12-31

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.

Conditions

Recurrent Glioblastoma Planned for Reoperation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Patupilone

Patupilone

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvia Hofer, MD

Role: PRINCIPAL_INVESTIGATOR

UniversitaetsSpital Zuerich

Other Identifiers

CEPO906A2401

Identifier Type: -

Identifier Source: org_study_id