Study With Nelfinavir and Combined Radiochemotherapy for Glioblastoma
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|ClinicalTrials.gov Identifier: NCT00694837|
Recruitment Status : Completed
First Posted : June 11, 2008
Last Update Posted : April 10, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Drug: nelfinavir||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study for Patients With Newly Diagnosed Glioblastoma Testing Nelfinavir in Combination With Concomitant Temozolomide and Radiotherapy.|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694837
|Maastricht Radiation Oncology|
|Maastricht, Netherlands, 6202 AZ|
|Principal Investigator:||Brigitta Baumert, MD PhD||Maastricht Radiation Oncology|