drugset / Trial / NCT01269424
BG & TMZ Therapy of Glioblastoma Multiforme
Non-randomizedParallel-groupOpen-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. O6-benzylguanine may help temozolomide work better by making tumor cells more sensitive to the drug. Giving genetically modified peripheral blood stem cells during or after treatment may prevent side effects caused by chemotherapy. PURPOSE: This clinical trial studies O6-benzylguanine and temozolomide in combination with genetically modified peripheral blood stem cells in treating patients with newly diagnosed glioblastoma multiforme.
Timeline
- Start
- 2011-11-22
- Primary completion
- 2020-12-07
- Completion
- 2022-09-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | MGMTP140K-encoding retroviral vector | Unknown | — | — |
| Comparator | O6-benzylguanine | Small molecule | 120 mg/m2 | Intravenous |
| Comparator | Temozolomide | Small molecule | 50 mg/m2 | — |
| Comparator | Temozolomide | Small molecule | 65 mg/m2 | — |
| Comparator | Temozolomide | Small molecule | 75 mg/m2 | — |
| Comparator | Temozolomide | Small molecule | 80 mg/m2 | — |
| Comparator | Temozolomide | Small molecule | 100 mg/m2 | — |
| Comparator | Temozolomide | Small molecule | 120 mg/m2 | — |
| Comparator | Temozolomide | Small molecule | 140 mg/m2 | — |
| Comparator | Temozolomide | Small molecule | 400 mg/m2 | — |