Investigation on safety, tolerability and efficacy of H-1 parvovirus (H-1PV) in subjects suffering from glioblastoma multiforme.

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.

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.