PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation

NCT01402063 ↗

Phase 2 Completed 63 enrolled Brown University MaineHealth · collab Milton S. Hershey Medical Center · collab Rhode Island Hospital · collab Thomas Jefferson University · collab University of California, San Diego · collab University of Massachusetts, Worcester · collab University of Washington · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

To obtain preliminary data in a randomized phase II study whether PPX/RT improves progression-free survival as compared to temozolomide/RT for patients with GBM without MGMT methylation.

Timeline

Start: 2011-09
Primary completion: 2014-04
Completion: 2015-06

Publications

Jeyapalan S, Boxerman J, Donahue J, Goldman M, Kinsella T, Dipetrillo T, Evans D, Elinzano H, Constantinou M, Stopa E, Puthawala Y, Cielo D, Santaniello A, Oyelese A, Mantripragada K, Rosati K, Isdale D, Safran H; Brown University Oncology Group Study. Paclitaxel poliglumex, temozolomide, and radiation for newly diagnosed high-grade glioma: a Brown University Oncology Group Study. Am J Clin Oncol. 2014 Oct;37(5):444-9. doi: 10.1097/COC.0b013e31827de92b.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Temozolomide	Small molecule	75 mg/m2	Oral
Subject	paclitaxel poliglumex	Other / unclassified	50 mg/m2	Intravenous

PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation

Summary

Timeline

Publications

Drugs

Indications