Study With Nelfinavir and Combined Radiochemotherapy for Glioblastoma
The objectives of the trial are:
To assess safety, tolerability and activity of nelfinavir given neo-adjuvant and concomitant to chemoradiotherapy with temozolomide in patients with a newly diagnosed glioblastoma multiforme.
To describe the possible effect of nelfinavir on functional imaging To describe the activity of nelfinavir in vivo on blocking the AKT pathway.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study for Patients With Newly Diagnosed Glioblastoma Testing Nelfinavir in Combination With Concomitant Temozolomide and Radiotherapy.|
- Fase I: To determine the MTD of nelfinavir as an adjuvant in the radiochemotherapy treatment in primary glioblastoma patients. Fase 2: Progression free survival at 6 months [ Time Frame: Fase 1: after treatment; fase 2: 6 months after treatment ] [ Designated as safety issue: Yes ]
- Fase 1/2: Incidence of acute toxicity; OS; Metabolic ratios of SUV of serial 18F-FDG: assessed by PET-CT.Fase 1:6-months PFS; Relative blood flow measurement by perfusion MRI. Fase 2: PFS at 12 months; Phosphorylation of AKT in tumour tissue. [ Time Frame: fase 1: 6 months after treatment; fase 2: 12 months after treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2009|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
The start dose of nelfinavir in phase 1 is 1000mg BID. The maximum administered dose, if no DLT occurs, will be1250 mg BID (2500mg). Nelfinavir will be administered 1 week before start of the chemoradiotherapy until the last day of chemoradiotherapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694837
|Maastricht Radiation Oncology|
|Maastricht, Netherlands, 6202 AZ|
|Principal Investigator:||Brigitta Baumert, MD PhD||Maastricht Radiation Oncology|