Conditions: Glioblastoma Multiforme
Keywords: Brain Tumors Glioblastoma Multiforme GBM
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 63
Healthy volunteers: no

Brief 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.

Detailed description:
To evaluate the toxicities of PPX/RT To evaluate neuro-cognitive functional assessments of patients with GBM receiving PPX/RT To obtain preliminary data in a randomized phase II study whether PPX/RT improves overall survival as compared to temozolomide /RT for patients with GBM without MGMT methylation to facilitate planning a phase III study.

Arms:
arm 1: Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments

\+ intravenous PPX every week x 6 weeks for a total of 6 treatments arm 2: Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments

\+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days

Interventions: intervention 1: PPX (CT2103) intervention 2: Temozolomide
Intervention descriptions: intervention 1: XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum. intervention 2: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum

Protocol document: