drugset / Trial / NCT00200161
Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma
Phase 2
Completed
127 enrolled
Memorial Sloan Kettering Cancer Center
Columbia University · collabDana-Farber Cancer Institute · collabSchering-Plough · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Patients have a newly diagnosed brain tumor called a malignant glioma and participate in the study to see if it is possible to increase the benefit of temozolomide when given after radiation. A recent study showed that patients with newly diagnosed glioblastoma lived longer when treated with both temozolomide and radiotherapy followed by 6 months of temozolomide than patients treated with radiotherapy alone. Patients will receive standard low dose temozolomide during radiation. After radiation, they will be randomized to receive either more intense temozolomide or continuous low dose temozolomide.
Timeline
- Start
- 2005-08-09
- Primary completion
- 2017-05-04
- Completion
- 2017-05-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Temozolomide | Small molecule | 50 mg/m2 | — |
| Subject | Temozolomide | Small molecule | 150 mg/m2 | — |
| Background | Isotretinoin | Other / unclassified | — | — |