Pegylated Liposomal Doxorubicine and Prolonged Temozolomide in Addition to Radiotherapy in Newly Diagnosed Glioblastoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

July 31, 2002

Primary Completion Date

May 31, 2009

Study Completion Date

May 31, 2009

Conditions
Glioblastoma
Interventions
DRUG

Pegylated Liposomal Doxorubicine

In the dose escalation phase of the study, PEG-Dox is raised in steps of 5 mg/m2 in a 3-by-3 design, starting with 5 mg/m2 (group 1) up to 20 mg/m2 (group 4). In the phase II part of the study, the targeted dose of 20 mg/m2 is administered up to a cumulative dose of 550 mg/m2 or until tumor progression.

Trial Locations (1)

93053

University of Regensburg, Department of Neurology, Regensburg

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Essex Pharma Germany

OTHER

lead

University of Regensburg

OTHER

NCT00944801 - Pegylated Liposomal Doxorubicine and Prolonged Temozolomide in Addition to Radiotherapy in Newly Diagnosed Glioblastoma | Biotech Hunter | Biotech Hunter