Brain Tumor Clinical Trial
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
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.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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