Phase II Study of ZK 219 477 in patients with recurrent glioblastoma - Epothilone in GBM

Conditions: Patients with recurrent GBM
MedDRA version: 9.1Level: LLTClassification code 10018336Term: Glioblastoma

Registration Number: EUCTR2006-001659-37-IT

Lead Sponsor: E.O.R.T.C. - EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 35

Inclusion Criteria

Patients with histologically proven glioblastoma.

♦ Recurrent disease documented by MRI after failing prior therapy

(usually standard RT with concomitant and maintenance

temozolomide).

♦ Patients with multifocal disease not amenable to radiotherapy are

eligible, provided they have received no or no more than 1 line of prior

chemotherapy.

♦ Presence of at least one bidimensionally measurable target lesion

(contrast enhancing lesion) with a largest diameter of at least 2cm,

based on MRI scan done within two weeks prior to the registration
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

No prior treatment with high dose radiotherapy (> 65 Gy), stereotactic

radiosurgery or internal radiation therapy unless the recurrence is

EORTC 26061 Epothilone in GBM

Version 1.0 8 / 67 31 May, 2006

subsequently histologically confirmed.

♦ Patients must not be taking antiepileptic agents or be on non-enzyme

inducing antiepileptic drugs (non-EIAED). Patients taking phenytoin,

carbamazepin or phenobarbital are not eligible.

No previous or current malignancy at other sites with the exception of

cone biopsied carcinoma of the cervix and adequately treated basal or

squamous cell skin carcinoma.