High grade glioma
Conditions
Brief summary
Clinical safety and tolerability will be assessed based on the observation of adverse events (AEs). AEs will be graded as per the NCI CTCAE v5. Patients will be assessed for AEs for 28 days following administration of SDT (marking study completion). Pathological findings of laboratory evaluations (specifically, complete blood counts and serum chemistries [including liver function tests] and physical examinations [including a detailed neurological examination]) will be documented as AEs.
Detailed description
Radiological changes: Changes on MRI between visit 1 (pre SDT) and visit 3 (post SDT) of tumor volume (enhancing tumor including necrosis, cm³), volume of FLAIR hyperintensity (cm³), volume of cytotoxic edema based on diffusion restriction on corresponding ADC and DWI sequences (cm³), relative cerebral blood volume (rCBVmax) and leakage (K2, 0.001/min)., Histopathological efficacy: Anti-tumor activity assessed by number of cells / mm³ with antibodies against IBA1 and number of cells / mm³ with antibodies against Caspase III
Interventions
Sponsors
Universitaet Muenster
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical safety and tolerability will be assessed based on the observation of adverse events (AEs). AEs will be graded as per the NCI CTCAE v5. Patients will be assessed for AEs for 28 days following administration of SDT (marking study completion). Pathological findings of laboratory evaluations (specifically, complete blood counts and serum chemistries [including liver function tests] and physical examinations [including a detailed neurological examination]) will be documented as AEs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiological changes: Changes on MRI between visit 1 (pre SDT) and visit 3 (post SDT) of tumor volume (enhancing tumor including necrosis, cm³), volume of FLAIR hyperintensity (cm³), volume of cytotoxic edema based on diffusion restriction on corresponding ADC and DWI sequences (cm³), relative cerebral blood volume (rCBVmax) and leakage (K2, 0.001/min)., Histopathological efficacy: Anti-tumor activity assessed by number of cells / mm³ with antibodies against IBA1 and number of cells / mm³ with antibodies against Caspase III | — |
Countries
Germany
Outcome results
None listed