Clinical Trials Search
Clinical Trial 18576
Interventions:Avastin (Bevacizumab); Bevacizumab; Lomustine (CeeNU); Not Applicable; Temodal (Temozolomide); Temozolomide; Toca 511; Toca FC
Study Type: Treatment
Phase of Study: Phase II/III
- Nam Tran
A Phase 2/3 Randomized, Open-Label Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC versus Standard of Care in Subjects Undergoing Planned Resection for Recurrent Glioblastoma or Anaplastic Astrocytoma
The purpose of this study is to: determine if the investigational products, Toca 511 and Toca FC, as a combination treatment is effective (works) and safe, compared to a selected number of approved treatments for brain tumors, called a control treatment.
Primary Objective: To compare the overall survival (OS) of subjects treated with Toca 511 combined with Toca FC to subjects treated according to standard of care after tumor resection for recurrence of glioblastoma or anaplastic astrocytoma. Secondary Objectives: 1. To evaluate the safety of each arm as administered in this study. 2. To assess the objective response rates of each arm. 3. To assess the clinical benefit rate (CR, PR or SD for >= 6 weeks) for each arm. 4. To compare the overall survival (OS) of subjects treated with Toca 511 combined with Toca FC to subjects treated according to standard of care after tumor resection for recurrence of glioblastoma which is IDH wild type. 5. To compare OS at 9, 12, 18 months (OS9, OS12, OS18) between arms. 6. To compare the patient reported outcome and quality of life between arms. 7. To compare progression-free survival (PFS) between arms. 8. To compare PFS at 6 months (PFS-6) between arms.