Safety Study of Replication-competent Adenovirus (Delta-24-rgd) in Patients With Recurrent Glioblastoma
|ClinicalTrials.gov Identifier: NCT01582516|
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : March 9, 2015
In the Netherlands a 2 center investigator-driven phase I/II clinical trial is initiated in June 2010 testing the oncolytic adenovirus Delta24-RGD to treat glioblastoma patients. The virus is administrated using convection-enhanced delivery by 4 catheters as delivery technique, targeting solid tumor as well as infiltrated tumor cells within the peri-tumoral brain. Patients will be enrolled in cohorts of 3 per dose-level. The dose levels to be explored are: 10^7, 10^8, 10^9, 10^10, 3*10^10 and 10^11 viral particles (vp). Once the MTD has been determined, or the study has reached the highest dose cohort, a further 6 or 9 patients will be enrolled at the MTD and evaluated for safety and preliminary signs of efficacy, such that in total at least 12 patients have received the MTD.
The primary objective is to determine the safety and tolerability of Delta-24-RGD administered by CED to the tumor and the surrounding infiltrated brain in patients with recurrent GBM. Secondary objectives are to determine the Progression Free Survival (PFS), Overall Survival (OS), and tumor response rate in patients with recurring tumors amenable for surgical resection and treated at the MTD.
Cerebrospinal fluid as well as brain interstitial fluid by microdialysis next to the routinely collected samples of blood at various timepoints before, during and after virus infusion. Various neurodegenerative biomarkers as well as markers of immune response will be assessed in these samples.
Furthermore extensive sampling and PCR analyses will be performed to evaluate distribution and shedding of the virus.
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumor Recurring Glioblastoma||Biological: delta-24-RGD adenovirus||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial of a Conditionally Replication-competent Adenovirus (Delta-24-rgd) Administered by Convection Enhanced Delivery in Patients With Recurrent Glioblastoma|
|Study Start Date :||June 2010|
|Primary Completion Date :||December 2014|
|Study Completion Date :||December 2014|
Intracerebral slow continuous infusion of study drug in increasing dose
Biological: delta-24-RGD adenovirus
slow continuous microinfusion in and around the brain tumor during 44 hrs.by 4 temporary placed catheters
- treatment related serious adverse events [ Time Frame: untill 3 months after treatment ]
- The number of participants alive after 6 months and after 1 year : Progression free survival after 6 months and overall survival after 6 months and one year. [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582516
|ERasmus Medical Center|
|Principal Investigator:||Clemens Dirven, MD PhD||Erasmus Medical Center|