Glioblastoma Multiforme
Conditions
Keywords
Progressive glioblastoma multiforme, Recurrent glioblastoma multiforme, Oncolytic virus
Brief summary
Investigation on safety, tolerability and efficacy of H-1 parvovirus (H-1PV) in subjects suffering from glioblastoma multiforme.
Detailed description
Investigation on safety, tolerability and efficacy of H-1 parvovirus (H-1PV) in subjects suffering from glioblastoma multiforme. H-1PV will primarily be administered either intratumoral or intravenously. Ten days thereafter a complete or a subtotal tumor resection with a subsequent administration of H-1PV into the walls of the resection cavity will be carried out.
Interventions
DRUGH-1PV
H-1PV administered at three increasing doses either intratumorally or intravenously and then 10 days after the first administration intracerebrally (into the walls of tumor resection cavity).
Sponsors
Oryx GmbH & Co. KG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age over or equal to 18 years old, * Diagnosis of glioblastoma multiforme, * Written informed consent, * Recurrent or progressive disease despite previous radio- and/or chemotherapy, * Indication for complete or subtotal tumor resection, * Life expectancy of at least 3 months, * Consent for sampling and investigation of biological specimens, * Karnofsky Performance Score over or equal to 60, * Adequate seizure control, * Adequate bone marrow function: neutrophils \> 1.5 x 10exp9/L, platelets \> 100 x 10exp9/L, hemoglobin \> 9.0 g/dL, * Adequate liver function: Bilirubin \< 2.0 g/dL, ASAT, ALAT, AP, GGT \< 3 x ULN, * Adequate renal function: Creatinine \< 1.8 g/dL, * Adequate blood clotting: aPTT \< 35 sec, INR \< 1.2, * Negative serology for HIV, HBV and HCV, * Negative Beta-HCG test in women of childbearing potential, * Commitment to use adequate contraception (in both genders) for up to six months after study entry, * Commitment to omit exposure to infants \< 18 months of age or immunocompromised individuals for up to 28 day after first administration of IMP.
Exclusion criteria
* Multifocal disease, * Evidence of distant tumor metastases, * Contraindications for MRI, * Active infection within 5 days prior to the study inclusion, * Chemotherapy within 4 weeks prior to the study inclusion, * Radiotherapy within 6 weeks prior to the study inclusion, * Participation in another interventional trial within the last 30 days, * Treatment with antiangiogenic substances within 21 days prior to therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | Up to 28 days after the first administration of the IMP | Parameters for assessment of safety and tolerability: * physical/neurological examinations (pathological findings as quality and quantity) * adverse events (quality and quantity per dose level) * vital signs, ECG, laboratory parameters (pathological findings as quality and quantity, for laboratory parameters: descriptive statistics) * viral shedding and viral specific antibodies (quantity depicted over time) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy (treatment response) | Up to 6 months after the first administration of the IMP | Parameters for evaluation of efficacy: * Progression free survival (PFS) based on modified RECIST-criteria depicted as Kaplan-Meier curve * Overall survival (OS) depicted as Kaplan-Meier curve |
Countries
Germany
Outcome results
None listed