EUCTR2006-001659-37-IT
Active, not recruiting
Not Applicable
Phase II Study of ZK 219 477 in patients with recurrent glioblastoma - Epothilone in GBM
E.O.R.T.C. - EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER0 sites35 target enrollmentJune 14, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- E.O.R.T.C. - EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER
- Enrollment
- 35
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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