A Phase 2 Study of MEDI-575 in Adult Subjects With Recurrent Glioblastoma Multiforme
The primary objective of this Phase II study is to evaluate the progression-free survival at 6 months in adult subjects with a first recurrence of Glioblastoma Multiforme who are treated with MEDI-575.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : MEDI-575
Phase: Phase 2
Ages Eligible For Study:
- Written informed consent and HIPAA authorization (applies to covered entities in the USA only) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations - Age ?18 years old at the time of screening - Histologically confirmed diagnosis of World Health Organization Grade IV malignant glioma (glioblastoma or gliosarcoma) - Previous first line treatment with radiotherapy and temozolomide (treatment prior to radiation and temozolomide permitted, [ie, Gliadel]) - Documented first recurrence of GBM by diagnostic biopsy or by contrast-enhanced magnetic resonance imaging (MRI) as per Updated Response Assessment Criteria of High Grade Gliomas- Neuro-Oncology Working Group (Wen et al, 2010) - Life expectancy ? 12 weeks - Adequate hematologic and organ function - Negative serum pregnancy test (women only) - Two methods of birth control for female participants of child-bearing potential or male participants with their female partners of child-bearing potential