drugset / Trial / NCT00528684
Safety and Efficacy Study of REOLYSIN® in the Treatment of Recurrent Malignant Gliomas
NaSingle-groupOpen-labelTreatment
Summary
RATIONALE: Oncolytic viruses such as reovirus (REOLYSIN®) can specifically kill tumor cells while leaving healthy cells unharmed. PURPOSE: This phase I/II study investigates the maximum tolerated dose (MTD), dose limiting toxicity (DLT) and anti-tumor effect of intralesional administration of REOLYSIN® therapeutic reovirus in patients with malignant glioma with evaluable disease which is progressive/recurrent despite surgery and/or radiotherapy with or without chemotherapy. (The phase I portion of the study is currently enrolling patients.)
Timeline
- Start
- 2006-07
- Primary completion
- 2010-04
- Completion
- 2010-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pelareorep | Other / unclassified | 1e+08 unknown | Other |
| Subject | Pelareorep | Other / unclassified | 3e+08 unknown | Other |
| Subject | Pelareorep | Other / unclassified | 1e+09 unknown | Other |
| Subject | Pelareorep | Other / unclassified | 3e+09 unknown | Other |
| Subject | Pelareorep | Other / unclassified | 1e+10 unknown | Other |