drugset / Trial / NCT01127594
Evaluate Safety/Tolerability Intra-Arterial Temozolomide in Patients w/Extremity Melanoma by Isolated Limb Infusion
Phase 1
Completed
29 enrolled
Douglas Tyler
Duke University · collabH. Lee Moffitt Cancer Center and Research Institute · collabM.D. Anderson Cancer Center · collabMerck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the safety profile of intra-arterial temozolomide administration during Isolated Limb Infusion (ILI) by defining the dose limiting toxicities associated with this treatment. This study also aims to determine the maximum tolerated dose of intra-arterial administration of temozolomide during ILI that will be used in a phase II trial.
Timeline
- Start
- 2010-07
- Primary completion
- 2013-08
- Completion
- 2014-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Temozolomide | Small molecule | 200 mg/m2 | Other |