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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05023434 -
A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
|
||
| Completed |
NCT04474678 -
Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!")
|
N/A | |
| Completed |
NCT02768389 -
Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma
|
Early Phase 1 | |
| Terminated |
NCT01902771 -
Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors
|
Phase 1 | |
| Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
| Recruiting |
NCT03286335 -
Local Control, Quality of Life and Toxicities in Adults With Benign or Indolent Brain Tumors Undergoing Proton Radiation Therapy
|
N/A | |
| Recruiting |
NCT05968053 -
Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
|
||
| Recruiting |
NCT05358340 -
Dual Perfusion Imaging for Characterizing Vascular Architecture of Brain Lesions
|
N/A | |
| Recruiting |
NCT03276676 -
[18F]Fluciclovine and [18F]FLT PET/CT Assessment of Primary High-Grade Brain Tumors
|
Phase 2 | |
| Completed |
NCT02851355 -
Follow-up Survey of Patients Who Were Treated for Medulloblastoma or Primitive Neuroectodermal Tumors of the Central Nervous in Norway
|
||
| Completed |
NCT02713087 -
Vasopressor Effects in Anesthetized Patients
|
Phase 4 | |
| Completed |
NCT02409121 -
A Novel Health Information Technology System (BMT Roadmap) for Pediatric BMT Patients and Caregivers
|
N/A | |
| Completed |
NCT02558569 -
The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block
|
Phase 4 | |
| Terminated |
NCT02674945 -
Understanding and Improving Quality of Life Through a Wireless Activity Tracker: Observational Phase
|
||
| Withdrawn |
NCT02165995 -
Use of Navigated Transcranial Magnetic Stimulation (nTMS) in Generated Motor and Language Mapping to Evaluate Brain Recovery Following Surgery
|
N/A | |
| Withdrawn |
NCT01202539 -
Real-time Assessment of Frameless Intrafraction Motion
|
||
| Completed |
NCT01171469 -
Vaccination With Dendritic Cells Loaded With Brain Tumor Stem Cells for Progressive Malignant Brain Tumor
|
Phase 1 | |
| Terminated |
NCT01044966 -
A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma
|
Phase 1/Phase 2 | |
| Completed |
NCT00760409 -
Differentiating Recurrent Brain Tumor Versus Radiation Injury Using MRI
|
N/A | |
| Completed |
NCT00503204 -
Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour
|
Phase 1 |