An Efficacy Study Of Ortataxel In Recurrent Glioblastoma

Inclusion Criteria

• •Histologically confirmed GBM.
• •GBM in recurrence/progression after surgery (or biopsy), standard radiotherapy and chemotherapy with Temozolomide.
• •Imaging confirmation of first tumor progression or regrowth as defined by the RANO criteria.
• •No more than one prior line of chemotherapy (Temozolomide).
• •Recovery from the toxic effects of prior therapy.
• •Patients who have undergone recent surgery for recurrent or progressive tumor are eligible provided that:
• •1. Surgery must have confirmed the recurrence.
• •2. A minimum of 14 days must have elapsed from the day of surgery to registration. For core or needle biopsy, a minimum of 7 days must have elapsed prior to registration.
• •3. Craniotomy or intracranial biopsy site must be adequately healed and free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of registration.
• •Age ≥ 18 years.
• •Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator.
• •Karnofsky-PS ≥ 60%.
• •Stable or decreasing dose of corticosteroids within 5 days prior to registration.