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Patupilone (EPO 906) in Patients With Recurrent or Progressive Glioblastoma Multiforme Prior to and After Secondary Resection: an Open-label Phase I/II Trial.


Phase 1/Phase 2
18 Years
80 Years
Not Enrolling
Both
Recurrent Glioblastoma Planned for Reoperation

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Trial Information

Patupilone (EPO 906) in Patients With Recurrent or Progressive Glioblastoma Multiforme Prior to and After Secondary Resection: an Open-label Phase I/II Trial.


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.

Inclusion 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 upper limit, creatinine
- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Silvia Hofer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UniversitaetsSpital Zuerich

Authority:

Switzerland: Swissmedic

Study ID:

CEPO906A2401

NCT ID:

NCT00715013

Start Date:

July 2008

Completion Date:

December 2010

Related Keywords:

  • Recurrent Glioblastoma Planned for Reoperation
  • recurrent Glioblastoma
  • Glioblastoma

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